A Comparison of BMS-232632 With Efavirenz, Each in Combination With Zidovudine-Lamivudine

Completed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare the effectiveness of treatment with BMS-232632 to that of efavirenz (EFV) when both are used with zidovudine (ZDV) and lamivudine (3TC).

Key facts

Study ID

NCT00013897

Run by

Bristol-Myers Squibb

Starts

2001-02-01

Expected to finish

2003-04-01

Last updated by the study team

2011-05-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Have a viral load of 2,000 or more copies/ml and a CD4 cell count of 100 or more cells/mm3 (or 75 or more cells/mm3 with no prior history of AIDS-defining diagnosis) within 2 weeks before randomization.
• Are at least 16 years old.
• Have signed consent of parent or guardian if under 18 years of age.
• Are willing to use effective barrier methods of birth control.
• Are available for follow-up for at least 52 weeks.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have had anti-HIV treatment within 30 days before screening.
• Have a recently diagnosed HIV-related infection.
• Have any medical condition requiring treatment at enrollment.
• Have recently become HIV infected.
• Have acute hepatitis within 30 days of study entry. Certain patients with chronic hepatitis will be eligible.
• Expect to need or have taken drugs with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months before study. Expect to need methadone, ribavirin/interferons, neurotoxic drugs or drugs that affect CYP3A4.
• Abuse alcohol or drugs.
• Have severe diarrhea within 30 days before study entry.
• Are pregnant or breast-feeding.
• Have a history of hemophilia.
• Have a history of bilateral peripheral neuropathy.
• Cannot take medicines by mouth.
• Have any other conditions that the doctor thinks would interfere with the study.

Where it is running

• Univ of Southern California — Los Angeles, California, United States
• Saint Francis Mem Hosp / HIV Care Unit — San Francisco, California, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• Dr Bruce Rashbaum — Washington D.C., District of Columbia, United States
• North Broward Hosp District / HIV Clinical Research — Fort Lauderdale, Florida, United States
• Associates in Research — Fort Myers, Florida, United States
• Steinhart Medical Associates — Miami, Florida, United States
• Saint Josephs Comprehensive Research Institute — Tampa, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• The CORE Ctr — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Univ of Michigan Hospitals and Health Ctrs — Ann Arbor, Michigan, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Univ of Nebraska Medical Ctr — Omaha, Nebraska, United States
• Robert Wood Johnson Med School/UMDNJ — New Brunswick, New Jersey, United States
• UMDNJ - New Jersey Med School — Newark, New Jersey, United States
• ID Care Inc — Somerville, New Jersey, United States
• Univ of NM — Albuquerque, New Mexico, United States
• Duke Univ Med Ctr / Infectious Disease Clinic — Durham, North Carolina, United States
• Jemsek Clinic — Huntersville, North Carolina, United States
• Ohio State Univ Hosp — Columbus, Ohio, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Methodist Healthcare — Memphis, Tennessee, United States
• Phoenix Body Positive — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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