Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00272779
Registration number
NCT00272779
Ethics application status
Date submitted
5/01/2006
Date registered
9/01/2006
Date last updated
9/05/2011
Titles & IDs
Public title
BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
Query!
Scientific title
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects
Query!
Secondary ID [1]
0
0
AI424-138
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
HIV Infections
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Acquired immune deficiency syndrome (AIDS / HIV)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - ATV
Treatment: Drugs - RTV
Treatment: Drugs - Tenofovi-Emtricitabine (TDF/FTC) tablet
Treatment: Drugs - LPV
Active Comparator: Atazanavir (ATV) + Ritonovir (RTV) - Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.
Active Comparator: Lopinavir (LPV) + RTV - Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.
Treatment: Drugs: ATV
300mg Oral capsules for 96 weeks
Treatment: Drugs: RTV
100mg Oral Capsules for 96 weeks
Treatment: Drugs: Tenofovi-Emtricitabine (TDF/FTC) tablet
One tablet with 300 mg - 200 mg once a day for 96 weeks.
Treatment: Drugs: LPV
400 mg (3 133mg capsules) BID for 96 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
Query!
Assessment method [1]
0
0
HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.
Query!
Timepoint [1]
0
0
Baseline (Day 1) and Week 48
Query!
Primary outcome [2]
0
0
Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
Query!
Assessment method [2]
0
0
Cmax was derived from plasma concentration versus time data.
Query!
Timepoint [2]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.
Query!
Primary outcome [3]
0
0
Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Query!
Assessment method [3]
0
0
AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.
Query!
Timepoint [3]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [4]
0
0
Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Query!
Assessment method [4]
0
0
Cmin was derived from the plasma concentration versus time data.
Query!
Timepoint [4]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [5]
0
0
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Query!
Assessment method [5]
0
0
Tmax was derived from the plasma concentration versus time data.
Query!
Timepoint [5]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [6]
0
0
Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Query!
Assessment method [6]
0
0
T-half was derived from the plasma concentration versus time data.
Query!
Timepoint [6]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [7]
0
0
Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
Query!
Assessment method [7]
0
0
EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(µM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).
Query!
Timepoint [7]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [8]
0
0
Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
Query!
Assessment method [8]
0
0
IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.
Query!
Timepoint [8]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [9]
0
0
Cmax of RTV at Week 4
Query!
Assessment method [9]
0
0
Cmax was derived from plasma concentration versus time data.
Query!
Timepoint [9]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [10]
0
0
AUC (0-24) of RTV at Week 4
Query!
Assessment method [10]
0
0
AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.
Query!
Timepoint [10]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [11]
0
0
Cmin of RTV at Week 4
Query!
Assessment method [11]
0
0
Cmin was derived from plasma concentration versus time data.
Query!
Timepoint [11]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [12]
0
0
Cmax of Tenofovir at Week 4
Query!
Assessment method [12]
0
0
Cmax was derived from plasma concentration versus time data.
Query!
Timepoint [12]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [13]
0
0
Cmin of Tenofovir at Week 4
Query!
Assessment method [13]
0
0
Cmin was derived from plasma concentration versus time data.
Query!
Timepoint [13]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [14]
0
0
AUC (TAU) of Tenofovir at Week 4
Query!
Assessment method [14]
0
0
AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.
Query!
Timepoint [14]
0
0
Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Query!
Primary outcome [15]
0
0
Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
Query!
Assessment method [15]
0
0
Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.
Query!
Timepoint [15]
0
0
Baseline (Day 1) and Week 96.
Query!
Primary outcome [16]
0
0
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
Query!
Assessment method [16]
0
0
19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].
Query!
Timepoint [16]
0
0
Baseline visit
Query!
Primary outcome [17]
0
0
Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
Query!
Assessment method [17]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [17]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [18]
0
0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
Query!
Assessment method [18]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [18]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [19]
0
0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
Query!
Assessment method [19]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [19]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [20]
0
0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
Query!
Assessment method [20]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [20]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [21]
0
0
Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
Query!
Assessment method [21]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [21]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [22]
0
0
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
Query!
Assessment method [22]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [22]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [23]
0
0
Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
Query!
Assessment method [23]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [23]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [24]
0
0
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
Query!
Assessment method [24]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [24]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [25]
0
0
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
Query!
Assessment method [25]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Query!
Timepoint [25]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [26]
0
0
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Query!
Assessment method [26]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).
Query!
Timepoint [26]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [27]
0
0
Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
Query!
Assessment method [27]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).
Query!
Timepoint [27]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [28]
0
0
Mean Change From Baseline in VAT Associated With RETN_730
Query!
Assessment method [28]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).
Query!
Timepoint [28]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Primary outcome [29]
0
0
Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
Query!
Assessment method [29]
0
0
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).
Query!
Timepoint [29]
0
0
Baseline (Day 1), Week 48, and Week 96.
Query!
Secondary outcome [1]
0
0
Number of Participants With HIV RNA < 400 c/mL at Week 48
Query!
Assessment method [1]
0
0
HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.
Query!
Timepoint [1]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [2]
0
0
Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)
Query!
Assessment method [2]
0
0
TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.
Query!
Timepoint [2]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [3]
0
0
Reduction of log10 HIV RNA Levels From Baseline to Week 48
Query!
Assessment method [3]
0
0
Changes from baseline in log10 HIV RNA levels were calculated.
Query!
Timepoint [3]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [4]
0
0
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Query!
Assessment method [4]
0
0
Mean change from baseline in CD4 cell counts was determined.
Query!
Timepoint [4]
0
0
Baseline (Day 1) and Week 48.
Query!
Secondary outcome [5]
0
0
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
Query!
Assessment method [5]
0
0
Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change
Query!
Timepoint [5]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [6]
0
0
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
Query!
Assessment method [6]
0
0
AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
Query!
Timepoint [6]
0
0
From baseline (Day 1) to Week 48.
Query!
Secondary outcome [7]
0
0
Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)
Query!
Assessment method [7]
0
0
Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.
Query!
Timepoint [7]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [8]
0
0
Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
Query!
Assessment method [8]
0
0
Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.
Query!
Timepoint [8]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [9]
0
0
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
Query!
Assessment method [9]
0
0
Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.
Query!
Timepoint [9]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [10]
0
0
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
Query!
Assessment method [10]
0
0
Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.
Query!
Timepoint [10]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [11]
0
0
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
Query!
Assessment method [11]
0
0
Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.
Query!
Timepoint [11]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [12]
0
0
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
Query!
Assessment method [12]
0
0
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.
Query!
Timepoint [12]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [13]
0
0
Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
Query!
Assessment method [13]
0
0
Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.
Query!
Timepoint [13]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [14]
0
0
Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
Query!
Assessment method [14]
0
0
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.
Query!
Timepoint [14]
0
0
At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Query!
Secondary outcome [15]
0
0
Mean Change in Weight From Baseline at Week 48
Query!
Assessment method [15]
0
0
Mean change in body weight from baseline was determined.
Query!
Timepoint [15]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [16]
0
0
Mean Change in Body Mass Index (BMI) in Participants at Week 48
Query!
Assessment method [16]
0
0
Mean change in BMI from baseline at Week 48 was determined.
Query!
Timepoint [16]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [17]
0
0
Mean Change in Fasting Lipid at Week 48
Query!
Assessment method [17]
0
0
Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.
Query!
Timepoint [17]
0
0
Baseline (Day 1) and Week 48.
Query!
Secondary outcome [18]
0
0
Mean Change in Fasting Glucose at Week 48
Query!
Assessment method [18]
0
0
Mean change from baseline in fasting glucose at Week 48.
Query!
Timepoint [18]
0
0
Baseline (Day 1) and Week 48.
Query!
Secondary outcome [19]
0
0
Mean Change in Fasting Insulin at Week 48
Query!
Assessment method [19]
0
0
Mean change from baseline in fasting insulin at Week 48.
Query!
Timepoint [19]
0
0
Baseline (Day 1) and Week 48.
Query!
Secondary outcome [20]
0
0
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
Query!
Assessment method [20]
0
0
Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.
Query!
Timepoint [20]
0
0
Baseline (Day 1) and Week 24.
Query!
Secondary outcome [21]
0
0
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
Query!
Assessment method [21]
0
0
MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.
Query!
Timepoint [21]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [22]
0
0
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
Query!
Assessment method [22]
0
0
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
Query!
Timepoint [22]
0
0
IBS-QoL is administered at baseline (Day 1) and Week 4.
Query!
Secondary outcome [23]
0
0
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
Query!
Assessment method [23]
0
0
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
Query!
Timepoint [23]
0
0
IBS-QoL is administered at baseline (Day 1) and Week 12.
Query!
Secondary outcome [24]
0
0
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)
Query!
Assessment method [24]
0
0
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
Query!
Timepoint [24]
0
0
Baseline (Day 1) and Week 24
Query!
Secondary outcome [25]
0
0
Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
Query!
Assessment method [25]
0
0
The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.
Query!
Timepoint [25]
0
0
Week 48
Query!
Secondary outcome [26]
0
0
Number of Participants With HIV RNA < 50 c/mL) at Week 96
Query!
Assessment method [26]
0
0
HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.
Query!
Timepoint [26]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [27]
0
0
Number of Participants With HIV RNA < 400 c/mL) at Week 96
Query!
Assessment method [27]
0
0
HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.
Query!
Timepoint [27]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [28]
0
0
Reduction of log10 HIV RNA Levels From Baseline at Week 96
Query!
Assessment method [28]
0
0
Changes from baseline in log10 HIV RNA levels were calculated.
Query!
Timepoint [28]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [29]
0
0
Mean Change From Baseline in CD4 Cell Count at Week 96
Query!
Assessment method [29]
0
0
Mean change from baseline in CD4 count among treated participants was determined.
Query!
Timepoint [29]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [30]
0
0
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
Query!
Assessment method [30]
0
0
AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
Query!
Timepoint [30]
0
0
From Day 1 through Week 96
Query!
Secondary outcome [31]
0
0
Mean Changes in Fasting Lipids at Week 96
Query!
Assessment method [31]
0
0
Mean change from baseline in fasting lipids at Week 96 was determined.
Query!
Timepoint [31]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [32]
0
0
Mean Changes in Fasting Glucose at Week 96
Query!
Assessment method [32]
0
0
Mean change from baseline in fasting glucose at Week 96 was determined.
Query!
Timepoint [32]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [33]
0
0
Mean Changes in Fasting Insulin at Week 96
Query!
Assessment method [33]
0
0
Mean change from baseline in fasting insulin at Week 96.
Query!
Timepoint [33]
0
0
Baseline (Day 1) and Week 96.
Query!
Secondary outcome [34]
0
0
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
Query!
Assessment method [34]
0
0
Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.
Query!
Timepoint [34]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [35]
0
0
Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
Query!
Assessment method [35]
0
0
Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.
Query!
Timepoint [35]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [36]
0
0
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
Query!
Assessment method [36]
0
0
Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.
Query!
Timepoint [36]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [37]
0
0
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
Query!
Assessment method [37]
0
0
Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.
Query!
Timepoint [37]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [38]
0
0
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
Query!
Assessment method [38]
0
0
Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.
Query!
Timepoint [38]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [39]
0
0
Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
Query!
Assessment method [39]
0
0
Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.
Query!
Timepoint [39]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [40]
0
0
Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
Query!
Assessment method [40]
0
0
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.
Query!
Timepoint [40]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [41]
0
0
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
Query!
Assessment method [41]
0
0
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.
Query!
Timepoint [41]
0
0
At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Query!
Secondary outcome [42]
0
0
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
Query!
Assessment method [42]
0
0
Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA = 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change
Query!
Timepoint [42]
0
0
Baseline (Day 1) and Week 96.
Query!
Secondary outcome [43]
0
0
Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
Query!
Assessment method [43]
0
0
Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.
Query!
Timepoint [43]
0
0
DEXA scans were taken at Baseline (Day 1) and at Weeks 48.
Query!
Secondary outcome [44]
0
0
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
Query!
Assessment method [44]
0
0
The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.
Query!
Timepoint [44]
0
0
DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.
Query!
Secondary outcome [45]
0
0
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
Query!
Assessment method [45]
0
0
The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.
Query!
Timepoint [45]
0
0
Baseline (Day 1) and Week 96.
Query!
Secondary outcome [46]
0
0
Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA
Query!
Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
Baseline (Day 1) and Week 96.
Query!
Secondary outcome [47]
0
0
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
Query!
Assessment method [47]
0
0
Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
Query!
Timepoint [47]
0
0
DEXA scans were taken at Baseline (Day 1) and Week 48.
Query!
Secondary outcome [48]
0
0
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
Query!
Assessment method [48]
0
0
Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
Query!
Timepoint [48]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [49]
0
0
Mean Change From Baseline in Body Weight at Week 96
Query!
Assessment method [49]
0
0
Mean change from baseline in weight at Week 96
Query!
Timepoint [49]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [50]
0
0
Mean Change From Baseline in Body Weight at Week 48
Query!
Assessment method [50]
0
0
Mean change from baseline in body weight at Week 48 was determined.
Query!
Timepoint [50]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [51]
0
0
Mean Change From Baseline in BMI at Week 96
Query!
Assessment method [51]
0
0
Query!
Timepoint [51]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [52]
0
0
Mean Change From Baseline in Waist Circumference at Week 96
Query!
Assessment method [52]
0
0
Mean change From baseline in waist circumference at Week 96 was determined.
Query!
Timepoint [52]
0
0
Baseline (Day 1) and Week 96.
Query!
Secondary outcome [53]
0
0
Mean Change From Baseline in Waist Circumference at Week 48
Query!
Assessment method [53]
0
0
Mean change from baseline in waist circumference at Week 48 was determined.
Query!
Timepoint [53]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [54]
0
0
Mean Change From Baseline in Waist-to-hip-ratio at Week 96
Query!
Assessment method [54]
0
0
Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.
Query!
Timepoint [54]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [55]
0
0
Mean Change From Baseline in BMI at Week 48
Query!
Assessment method [55]
0
0
Mean change from baseline in BMI at Week 48 was determined.
Query!
Timepoint [55]
0
0
Baseline (Day 1) and Week 48.
Query!
Secondary outcome [56]
0
0
Mean Change From Baseline in Waist-to-hip-ratio at Week 48
Query!
Assessment method [56]
0
0
Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.
Query!
Timepoint [56]
0
0
Baseline (Day 1) and Week 48
Query!
Secondary outcome [57]
0
0
Percentage of Participants With Lipoatrophy at Week 96
Query!
Assessment method [57]
0
0
Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.
Query!
Timepoint [57]
0
0
Baseline (Day 1) and Week 96
Query!
Secondary outcome [58]
0
0
Mean Changes From Baseline in Body Weight at Week 96
Query!
Assessment method [58]
0
0
Mean change in body weight from baseline was determined.
Query!
Timepoint [58]
0
0
Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.
Query!
Secondary outcome [59]
0
0
Mean Change From Baseline in BMI at Week 96
Query!
Assessment method [59]
0
0
Mean change From baseline in BMI at Week 96 was determined.
Query!
Timepoint [59]
0
0
Baseline (Day 1) and Week 96
Query!
Eligibility
Key inclusion criteria
- HIV RNA =5000 c/ml
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Any antiretroviral therapy within 30 days prior to screening;
- Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable
method to avoid pregnancy for the entire study and for up to 8 weeks after the study;
- WOCBP using a prohibited contraceptive method
- WOCBP who are pregnant or breastfeeding;
- Women with a positive pregnancy test on enrollment or prior to study drug
administration;
- Presence of a newly diagnosed HIV-Related opportunistic infection or any medical
condition requiring acute therapy at the time of enrollment;
- Suspected primary (acute) HIV infection;
- Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse
transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within
30 days prior to screening; some exceptions are allowed for ARV therapy in use for
Mother-to-child transmission;
- Participants with Cushing's syndrome;
- Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a
stable replacement dose of thyroid hormone is acceptable provided the thyroid
stimulating hormone (TSH) performed within 30 days of screening is within normal drug
range;
- Recent therapy with agents with significant systemic myelosuppressive, neurotoxic,
pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or
expected need for such therapy at the time of enrollment; or therapy with methadone or
ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;
- Participants with obstructive liver disease;
- Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent
adequate compliance with study therapy or to increase the risk of developing
pancreatitis or chemical hepatitis;
- Proven or suspected acute hepatitis in the 30 days prior to study entry;
- Intractable diarrhea (=6 loose stools/day for at least 7 consecutive days) within 30
days prior to study entry;
- Inability to swallow capsules;
- Active peripheral neuropathy;
- Presence of cardiomyopathy (due to any cause) or any significant cardiovascular
disease, such as unstable ischemic heart disease;
- Known, clinically significant cardiac conduction system disease.
- Baseline laboratory values measured within 2 weeks prior to initiating study drugs as
follows:
1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault
equation;
2. total serum lipase = 1.4 times the upper limit of normal;
3. liver enzymes (AST, ALT) = 5 times the upper limit of normal;
4. total serum bilirubin = 1.5 times the upper limit of normal.
- Hypersensitivity to any component of the formulation of study drug;
- Prohibited therapies;
- Any other clinical conditions or prior therapy that, in the opinion of the
Investigator, would make the participant unsuitable for study or unable to comply with
the dosing requirements;
- Prisoners or participants who are compulsorily detained (involuntarily incarcerated)
for treatment of either a psychiatric or physical (e.g., infectious disease) illness
must not be enrolled into this study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1057
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Local Institution - Carlton
Query!
Recruitment hospital [3]
0
0
Local Institution - South Yarra
Query!
Recruitment postcode(s) [1]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
- Carlton
Query!
Recruitment postcode(s) [3]
0
0
- South Yarra
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Texas
Query!
Country [7]
0
0
Argentina
Query!
State/province [7]
0
0
Buenos Aires
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Santa Fe
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Cordoba
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Wien
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Brugge
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Gent
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Parana
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Pernambuco
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Sao Paulo
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Rio De Janeiro
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Ontario
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Quebec
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Metropolitana
Query!
Country [20]
0
0
Chile
Query!
State/province [20]
0
0
Valparaiso
Query!
Country [21]
0
0
Colombia
Query!
State/province [21]
0
0
Bogota
Query!
Country [22]
0
0
Costa Rica
Query!
State/province [22]
0
0
San Jose
Query!
Country [23]
0
0
Dominican Republic
Query!
State/province [23]
0
0
Santo Domingo
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Nice Cedex
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris Cedex 10
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Paris Cedex 13
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Paris Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Villejuif
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Berlin
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Bonn
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hamburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Koeln
Query!
Country [33]
0
0
Guatemala
Query!
State/province [33]
0
0
Guatemala
Query!
Country [34]
0
0
Hong Kong
Query!
State/province [34]
0
0
Kowloon
Query!
Country [35]
0
0
Indonesia
Query!
State/province [35]
0
0
Jakarta
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Genova
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Milano
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Roma
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Torino
Query!
Country [40]
0
0
Mexico
Query!
State/province [40]
0
0
Distrito Federal
Query!
Country [41]
0
0
Mexico
Query!
State/province [41]
0
0
Jalisco
Query!
Country [42]
0
0
Mexico
Query!
State/province [42]
0
0
Chihuaha
Query!
Country [43]
0
0
Mexico
Query!
State/province [43]
0
0
Durango
Query!
Country [44]
0
0
Mexico
Query!
State/province [44]
0
0
San Luis Potisi
Query!
Country [45]
0
0
Netherlands
Query!
State/province [45]
0
0
Maastricht
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Utrecht
Query!
Country [47]
0
0
Panama
Query!
State/province [47]
0
0
Panama
Query!
Country [48]
0
0
Peru
Query!
State/province [48]
0
0
Lima
Query!
Country [49]
0
0
Portugal
Query!
State/province [49]
0
0
Lisboa
Query!
Country [50]
0
0
Portugal
Query!
State/province [50]
0
0
Lisbon
Query!
Country [51]
0
0
Puerto Rico
Query!
State/province [51]
0
0
Ponce
Query!
Country [52]
0
0
Puerto Rico
Query!
State/province [52]
0
0
San Juan
Query!
Country [53]
0
0
Singapore
Query!
State/province [53]
0
0
Singapore
Query!
Country [54]
0
0
South Africa
Query!
State/province [54]
0
0
Eastern Cape
Query!
Country [55]
0
0
South Africa
Query!
State/province [55]
0
0
Free State
Query!
Country [56]
0
0
South Africa
Query!
State/province [56]
0
0
Gauteng
Query!
Country [57]
0
0
South Africa
Query!
State/province [57]
0
0
Kwa Zulu Natal
Query!
Country [58]
0
0
South Africa
Query!
State/province [58]
0
0
Western Cape
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Barcelona
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Cordoba
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Madrid
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Malaga
Query!
Country [63]
0
0
Taiwan
Query!
State/province [63]
0
0
Kaohsiung
Query!
Country [64]
0
0
Taiwan
Query!
State/province [64]
0
0
Taipei
Query!
Country [65]
0
0
Thailand
Query!
State/province [65]
0
0
Chiang Mai
Query!
Country [66]
0
0
Thailand
Query!
State/province [66]
0
0
Khonkaen
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Greater London
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Greater Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of
atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV.
A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by
participants in both arms.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00272779
Query!
Trial related presentations / publications
Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):323-32. doi: 10.1097/QAI.0b013e3181c990bf.
Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Thiry A, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008 Aug 23;372(9639):646-55. doi: 10.1016/S0140-6736(08)61081-8.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00272779
Download to PDF