PER-076-00
Completed
未知
A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 with Efavirenz; Each in Combination with Fixed Dose Zidovudine-Lamivudine
BRISTOL MYERS SQUIBB PERU S.A.,0 sites0 target enrollmentJanuary 1, 2000
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -B22 Human immunodeficiency virus [HIV] disease resulting in other specified diseases
- Sponsor
- BRISTOL MYERS SQUIBB PERU S.A.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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;
Outcomes
Primary Outcomes
Not specified
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