A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavirwith Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabinein HIV-1 Infected Treatment Naive Subjects.Revised Protocol 01: Incorporates changes from Amendment 03.Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; andMetabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05

Phase 1

• Conditions: HIV-1 Infected Treatment Naive Subjects

• Registration Number: EUCTR2005-001895-11-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-21
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

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. In the specific setting of antiretroviral treatment for reduction of risk of mother-to-child transmission, the following criteria will apply:
• = 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;
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 disease. This includes severe first degree atrioventricular block (PR interval > 0.26 seconds) as well as second and third-degree atrioventricular block;
20) Moderate to Severe hepatic insufficiency (screening Child-Pugh Score > 6 (Classes B or C)) (see Protocol Appendix 13);
21) Screening laboratory values measured as follows;:
a) Calculated creatinine clearance < 60 mL/min as estimated by the Cockcroft-Gault equation:
For men, (140 – age in years) x (body weight in kg) ÷ (serum
creatinine in mg/dL x 72) = CrCl (mL/min)
For women, multiply the result by 0.85
b) total serum lipase = 1.4 times the upper limit of normal,
c) liver enzymes (AST, ALT) = 5 times the upper limit of normal,
d) total serum bilirubin = 1.5 times the upper limit of normal.
22) Hypersensitivity to any component of the formulation of study drug;
23) Prohibited therapies and/or medication (see Protocol Appendix 8);
24) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements;
25) Prisoners or subjects who are compulsorily detained.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified