Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

Key facts

Study ID

NCT00002240

Run by

Bristol-Myers Squibb

Starts

1999-03-01

Expected to finish

2001-12-01

Last updated by the study team

2011-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Have an HIV blood level between 2,000 and 200,000 copies/ml.
• Have a CD4 cell count of at least 100 cells/mm3.
• Are 18 years of age or older.
• Are available for follow-up for at least 48 weeks.
• Agree to use a barrier method of birth control (such as condoms) during the study.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have ever received anti-HIV (antiretroviral) treatment.
• Have an HIV-related opportunistic infection or condition at the time of study entry.
• Have primary HIV infection, meaning they have recently been infected.
• Have had severe diarrhea within the 30 days before study entry.
• Have hemophilia.
• Have a history of pancreatitis, hepatitis, or a peripheral neuropathy.
• Are unable to tolerate oral medication.
• Are pregnant or breast-feeding.
• Abuse alcohol or drugs.

Where it is running

• Clinsites / Sorra Research Ctr — Birmingham, Alabama, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• UCSD Treatment Ctr — San Diego, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Univ of Colorado / Health Science Ctr — Denver, Colorado, United States
• ViRx / Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Albany Med College — Albany, New York, United States
• Beth Israel Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• Oak Lawn Physicians Group — Dallas, Texas, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Ottawa General Hospital — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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