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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00043966




Registration number
NCT00043966
Ethics application status
Date submitted
15/08/2002
Date registered
19/08/2002
Date last updated
27/07/2006

Titles & IDs
Public title
Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
Scientific title
A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
Secondary ID [1] 0 0
M02-418
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lopinavir/ritonavir
Treatment: Drugs - Tenofovir DF
Treatment: Drugs - Emtricitabine

Treatment: Drugs: Lopinavir/ritonavir


Treatment: Drugs: Tenofovir DF


Treatment: Drugs: Emtricitabine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Subject is at least 18 years of age.

- If female, subject is not of childbearing potential, defined as postmenopausal for at
least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy
or hysterectomy), or is of childbearing potential and practicing one of the following
methods of birth control: *condoms, sponge, foams, jellies, diaphragm or intrauterine
device (IUD) *contraceptives (oral or parenteral) for three months prior to study drug
administration) *a vasectomized partner *total abstinence from sexual intercourse

- If female, the results of a urine pregnancy test performed at screening (urine
specimen obtained no earlier than 28 days prior to study drug administration) and a
urine pregnancy test performed on Study Day -1 are both negative and the subject
agrees to use a barrier method of contraception throughout the study.

- Subject is not breast-feeding.

- Vital signs, physical examination and laboratory results do not exhibit evidence of
acute illness.

- Subject has no significant history of cardiac, renal, neurologic, psychiatric,
oncologic, endocrinologic, metabolic or hepatic disease that would adversely affect
his/her participating in this study.

- Subject does not require and agrees not to take any of the following medications for
the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride,
pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine,
dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin,
simvastatin, and St. John's wort.

- Subject agrees not to take any medication during the study, including over-the-counter
medicine, herbal medications, alcohol or recreational drugs without the knowledge and
permission of the principal investigator.

- Subject has a Karnofsky Score greater than or equal to 70

- Subject has not been treated for an active AIDS-defining opportunistic infection
within 30 days of screening. Subjects who are on stable maintenance therapy for an
opportunistic infection may be enrolled after consultation with Abbott.

- Subject is naive to antiretroviral treatment (< 7 days ARV treatment).

- Subject has a plasma HIV RNA level of greater than 1,000 copies/mL at screening.

- Subject agrees to take all doses of the lopinavir/ritonavir from the bottles provided
by the sponsor (rather than take doses from a personal "dosette" box).

- Subject has voluntarily signed and dated an informed consent form, approved by an
Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature
of the study has been explained and the subject has had the opportunity to ask
questions. The informed consent must be signed before any study-specific procedures
are performed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has a history of an allergic reaction or significant sensitivity to
lopinavir/ritonavir, tenofovir or emtricitabine or to drugs similar to study drug.

- Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.

- Subject has a positive result on the screening tests for drugs of abuse.

- Subject has a history of substance abuse or psychiatric illness that could preclude
adherence with the protocol.

- Screening laboratory analyses show any of the following abnormal laboratory results:
*Hemoglobin = 8.0 g/dL *Absolute neutrophil count = 750 cells/µL *Platelet count =
50,000 per mL *ALT or AST = 3.0 x Upper Limit of Normal (ULN) *Creatinine = 1.5 x
Upper Limit of Normal (ULN)

- Subject has received any investigational drug within 30 days prior to study drug
administration.

- For any reason, subject is considered by the investigator to be an unsuitable
candidate for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Ground Zero Medical Centre / AIDS Research Initiative - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House General Practice - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
France
State/province [16] 0 0
Cedex 10
Country [17] 0 0
France
State/province [17] 0 0
Cedex 12
Country [18] 0 0
France
State/province [18] 0 0
Cedex 20
Country [19] 0 0
France
State/province [19] 0 0
Le Kremlin Bicetre
Country [20] 0 0
France
State/province [20] 0 0
Nice
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Koln
Country [24] 0 0
Singapore
State/province [24] 0 0
Tan Tock Seng
Country [25] 0 0
Spain
State/province [25] 0 0
Badalona
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
United Kingdom
State/province [28] 0 0
E. Sussex
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the safety, tolerability and antiviral activity
between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further
characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00043966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Brun, M.D.
Address 0 0
Global Project Head, Antiviral Global Project Team
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00043966