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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00824421
Registration number
NCT00824421
Ethics application status
Date submitted
15/01/2009
Date registered
16/01/2009
Date last updated
24/01/2014
Titles & IDs
Public title
A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
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Scientific title
A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
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Secondary ID [1]
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A5271015
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV-1
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - UK-453, 061
Treatment: Drugs - UK-453, 061
Treatment: Drugs - EFV +TVA
Experimental: UK- 453,061 Dose One - UK 453,061 Dose One plus Truvada
Experimental: UK-453,061 Dose Two - UK 453,061 Dose Two plus Truvada
Active Comparator: Efavirenz + Truvada - Efavirenz + Truvada
Treatment: Drugs: UK-453, 061
UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
Treatment: Drugs: UK-453, 061
UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.
Treatment: Drugs: EFV +TVA
Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48
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Assessment method [1]
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Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96
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Assessment method [1]
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Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
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Timepoint [1]
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Week 24, 96
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Secondary outcome [2]
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Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96
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Assessment method [2]
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Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
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Timepoint [2]
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Week 24, 48, 96
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Secondary outcome [3]
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Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
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Assessment method [3]
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For the log 10 scale, all the HIV-1 RNA levels were log 10 transformed prior to the average calculations. Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.
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Timepoint [3]
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Baseline, Week 24, 48, 96
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Secondary outcome [4]
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Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
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Assessment method [4]
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TAD was calculated as area under the curve of HIV-1 RNA levels (log10 copies/mL) from baseline to the time point of interest divided by time period in weeks minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.
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Timepoint [4]
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Baseline up to Week 24, 48, 96
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Secondary outcome [5]
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Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96
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Assessment method [5]
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TLOVR50 response is compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; met treatment failure [TF] criteria). TF: an increase to at least 3 times baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL). TF criteria's defined above were confirmed by second measurement at least 14 days after first. In 'TLOVR50', '50' denotes the lower limit of quantification (LLOQ) of assay (which is 50 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.
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Timepoint [5]
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Week 24, 48, 96
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Secondary outcome [6]
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Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96
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Assessment method [6]
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Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.
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Timepoint [6]
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Baseline, Week 24, 48, 96
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Secondary outcome [7]
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Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96
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Assessment method [7]
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Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.
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Timepoint [7]
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Baseline, Week 24, 48, 96
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Secondary outcome [8]
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Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96
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Assessment method [8]
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Phenotypic resistance and genotypic resistance was assessed for all participants at Day 1 predose, and was evaluated for nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) resistance-associated mutations at time of treatment failure using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure, up to Week 96.
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Timepoint [8]
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Day 1 (pre-dose) through Week 24, 48, 96
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Secondary outcome [9]
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Number of Participants With Laboratory Test Abnormalities
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Assessment method [9]
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Laboratory analysis included hematology, blood chemistry, serum and urine pregnancy test, hepatitis testing and urinalysis. Laboratory values that met the criteria of the Division of Acquired Immuno Deficiency Syndrome (DAIDS) grade 1 (mild, symptoms causing no or minimal interference with usual social and functional activities) or greater were considered as abnormal.
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Timepoint [9]
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Baseline up to Week 96 or early termination
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Secondary outcome [10]
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Population Pharmacokinetic (PK) of Lersivirine
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Assessment method [10]
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Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the participant flow and baseline characteristics modules.
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Timepoint [10]
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Week 2, 4, 8, 12, 16, 24, 32, 40, 48
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Secondary outcome [11]
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Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)
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Assessment method [11]
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Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.
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Timepoint [11]
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Week 2, 4, 8, 12, 16, 24, 32, 40, 48
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Secondary outcome [12]
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Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine
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Assessment method [12]
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AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0-24). Only participants from Lersivirine treatment arms were planned to be analyzed for Pharmacokinetic (PK) sub-study.
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Timepoint [12]
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0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4
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Secondary outcome [13]
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Maximum Observed Plasma Concentration (Cmax) of Lersivirine
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Assessment method [13]
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Timepoint [13]
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0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
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Secondary outcome [14]
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine
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Assessment method [14]
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Timepoint [14]
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0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
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Secondary outcome [15]
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Plasma Concentration of Lersivirine at 24 Hour
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Assessment method [15]
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The observed plasma concentration at 24 hours post-dose (C 24h).
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Timepoint [15]
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24 hrs post-dose on Week 4
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Eligibility
Key inclusion criteria
- Male or female at least 18 years of age available for a follow-up period of at least
96 weeks.
- HIV 1 RNA viral load of greater then 1,000 copies/mL
- Negative urine pregnancy test.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Suspected or documented active, untreated HIV-1 related opportunist infection or other
condition requiring acute therapy at the time of randomization.
- Subjects with acute Hepatitis B and/or C within 30 days of randomization.
- Absolute CD4 count <200 cells/mm3.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2011
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Sample size
Target
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Accrual to date
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Final
195
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Darlinghurst
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Recruitment hospital [2]
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Pfizer Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Canada
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State/province [3]
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Quebec
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Country [4]
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Italy
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State/province [4]
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Milano
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Country [5]
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Italy
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State/province [5]
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Torino
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Country [6]
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Mexico
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State/province [6]
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Distrito Federal
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Country [7]
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Poland
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State/province [7]
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Bydgoszcz
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Country [8]
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Poland
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State/province [8]
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Gdansk
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Country [9]
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Poland
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State/province [9]
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Lodz
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Country [10]
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Poland
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State/province [10]
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Warszawa
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Country [11]
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South Africa
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State/province [11]
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Gauteng
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Country [12]
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South Africa
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State/province [12]
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Kwa Zulu Natal
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Country [13]
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South Africa
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State/province [13]
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Limpopo
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Country [14]
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South Africa
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State/province [14]
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Western Cape
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Country [15]
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South Africa
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State/province [15]
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Pretoria
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Country [16]
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Switzerland
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State/province [16]
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CH-8091 Zurich
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Country [17]
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Switzerland
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State/province [17]
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Lugano
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Country [18]
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Switzerland
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State/province [18]
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St. Gallen
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Country [19]
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United Kingdom
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State/province [19]
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Greater Manchester
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Country [20]
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United Kingdom
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State/province [20]
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Brighton
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Country [21]
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United Kingdom
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State/province [21]
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Edinburgh
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Country [22]
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United Kingdom
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State/province [22]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as
efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected
patients who have not been previously treated with antiretroviral drugs.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00824421
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00824421
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