A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 with Efavirenz; Each in Combination with Fixed Dose Zidovudine-Lamivudine
- Conditions
- -B22 Human immunodeficiency virus [HIV] disease resulting in other specified diseasesHuman immunodeficiency virus [HIV] disease resulting in other specified diseasesB22
- Registration Number
- PER-076-00
- Lead Sponsor
- BRISTOL MYERS SQUIBB PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Qualifying plasma HIV RNA > 2,000 c/mL and a CD4 cell count of 3 3 > 100 cells/mm (or > 75 cells/mm with no prior history of any AIDS-defining diagnoses) obtained within 2 weeks prior to randomization;
• >16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate);
• Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted;
• Subjects must be able to provide written informed consent;
• Subjects should be available for follow-up for a period of at least 52 weeks;
• Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:
o serum creatinine < 1.5 times the upper limit of normal,
o total serum lipase < 1.4 times the upper limit of normal,
o liver enzymes (AST, ALT) < 3 times the upper limit of normal,
o total serum bilirubin < 1.5 times the upper limit of normal.
• Prior antiretroviral therapy (< 30 days of nucleoside and/or < 7 days of NNRTI or protease inhibitor therapies will be permitted, provided that the last dose(s) was/were >30 days prior to screening);
• 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;
• Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are < 3 times the upper limit of normal;
• Previous 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;
• Active alcohol or substance abuse sufficient, in the Investigator´s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
• Intractable diarrhea (> 6 loose stools/day for at least 7 consecutive days) within
• 30 days prior to study entry;
• Pregnancy or breast-feeding;
• History of hemophilia;
• History or signs and symptoms of bilateral peripheral neuropathy > Grade 2 at the time of screening;
• Inability to tolerate oral medication;
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Physical Exam, Plasma HIV RNA<br>Measure:The difference in proportion of subjects responding to treatment with plasma HIV RNA levels < 400 c/mL at Week 48.<br>Timepoints:Weeks 4, 8, 12, 16; then eyery 8 weeks<br>;<br>Outcome name:Registry of Adverse Events/Clinical Complaints<br>Measure:The number and severity of adverse events, serious adverse events (clinical or laboratory), and the time to treatment discontinuation.<br>Timepoints:Weeks 1, 2, 4, 8, 12, 16, then eyery 8 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Physical Exam, Plasma HIV RNA<br>Measure:The proportion of subjects responding to treatment with plasma HIV RNA < 50 c/mL at 48 weeks<br>Timepoints:Week 48<br>;<br>Outcome name:Plasma HIV RNA<br>Measure:The magnitude and durability of plasma HIV RNA of changes from Baseline assessed for each treatment group through 48 weeks of therapy;<br>Timepoints:Week 48<br>;<br>Outcome name:CD4/CD8 count<br>Measure:The magnitude and durability of rises in CD4 cell counts in terms of the change from baseline will be assessed for each treatment group through 48 weeks of therapy.<br>Timepoints:On the first day, then weeks 4, 8, 12, 16, then eyery 8 weeks<br>;<br>Outcome name:Registry of Adverse Events/Clinical Complaints<br>Measure:The number of mild-moderate adverse events (clinical or laboratory).<br>Timepoints:Weeks 1, 2, 4, 8, 12, 16, then eyery 8 weeks<br>