A Phase III Study Comparing the Antiviral Efficacy and Safety of BMS-232632 with Efavirenz; Each in Combination with Fixed Dose Zidovudine-Lamivudine

Not Applicable

Completed

• Conditions: -B22 Human immunodeficiency virus [HIV] disease resulting in other specified diseases; Human immunodeficiency virus [HIV] disease resulting in other specified diseases; B22

• Registration Number: PER-076-00
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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;
• 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