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 Naive Subjects. Revised Protocol 04 Incorporating changes from Amendment 03, 04, 05, 06 (Version 1.0, Date 03-Apr-2007), and Administrative Letter dated 31-Oct-2006. Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; and Metabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05
- Conditions
- HIV-1 Infected Treatment Naive Subjects
- Registration Number
- EUCTR2005-001895-11-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
1) Provide written informed consent and assess whether the subject is capable of reading and comprehending the informed consent;
2) Qualifying plasma HIV RNA = 5000 c/mL obtained at screening;
3) Men and women, ages 18 years and older (or minimum age as determined by local regulatory or as legal requirements dictate).
4) Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized. Both females and males must utilize effective barrier contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
2) WOCBP using a prohibited contraceptive method (see Protocol Appendix 8);
3) Women who are pregnant or breastfeeding;
4) Women with a positive pregnancy test on enrollment or prior to study drug administration;
5) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
6) Suspected primary (acute) HIV infection;
7) Any antiretroviral therapy within 30 days prior to screening
8) Prior antiretroviral therapy = 1 week.
However in specific settings of antiretroviral treatment including
a/ post exposure prophylaxis (PEP)
b/ pre-exposure prophylaxis (PREP) and/or
c/ HAART exposure for reduction of risk of mother-to-child transmission,
the following prior antiretroviral exposure exceptions will apply, allowing the subject entry into the study:
•< 6 weeks of triple antiretroviral therapy (3 drugs of any class)
or
•< 4 weeks of dual antiretroviral therapy (2 drugs of any class)
or
•<1 week of mono-antiretroviral therapy (1 drug of any class)
9) Subjects with Cushing’s syndrome;
10) Untreated hypothyroidism or hyperthyroidism;
11) Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the 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 (see Protocol Section 6.4 and Appendix 8);
12) Subjects with obstructive liver disease;
13) 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;
14) Proven or suspected acute hepatitis in the 30 days prior to study entry;
Note: Chronic co-infection with hepatitis C and/or B are not exclusion criteria.
Subjects with acute hepatitis infection may have the option to be screened after the
event has evolved into a chronic infection.
HBV co-infected subjects participating in this trial; and interrupting study therapy are
at an increased risk of developing elevations in hepatic transaminases due to prior
reports of exacerbations of hepatitis in patients after the discontinuation of
TDF/FTC.15 Subjects with HBV co-infection are required to have an additional
6 months of follow-up after stopping study medications.
15) Intractable diarrhea (= 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;
16) Inability to swallow capsules;
17) Active peripheral neuropathy;
18) Presence of cardiomyopathy or any significant cardiovascular disease;
19) Known, clinically significant cardiac conduction system dis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method