None listed
Conditions
Interventions
BMS-232632 (2 x 200 mg) QD + EFV placebo (3 capsules)
QD + ZDV-3TC 300 mg/150 mg BID
Group name:Group II Type of group
EFV (3 x 200 mg) QD + BMS-232632 placebo (2 capsules)
QD + ZDV-3TC 300 mg/150 mg BID
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • Prior antiretroviral therapy (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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical Exam, Plasma HIV RNA Measure:The difference in proportion of subjects responding to treatment with plasma HIV RNA levels < 400 c/mL at Week 48. Timepoints:Weeks 4, 8, 12, 16; then eyery 8 weeks ; Outcome name:Registry of Adverse Events/Clinical Complaints Measure:The number and severity of adverse events, serious adverse events (clinical or laboratory), and the time to treatment discontinuation. Timepoints:Weeks 1, 2, 4, 8, 12, 16, then eyery 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Physical Exam, Plasma HIV RNA Measure:The proportion of subjects responding to treatment with plasma HIV RNA < 50 c/mL at 48 weeks Timepoints:Week 48 ; Outcome name:Plasma HIV RNA Measure:The magnitude and durability of plasma HIV RNA of changes from Baseline assessed for each treatment group through 48 weeks of therapy; Timepoints:Week 48 ; Outcome name:CD4/CD8 count 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. Timepoints:On the first day, then weeks 4, 8, 12, 16, then eyery 8 weeks ; Outcome name:Registry of Adverse Events/Clinical Complaints Measure:The number of mild-moderate adverse events (clinical or laboratory). Timepoints:Weeks 1, 2, 4, 8, 12, 16, then eyery 8 weeks | — |
Outcome results
None listed