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Home > "S" Clinical Trials Conditions > Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs  Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs
Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details: Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment:
Location and Contact Information:
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Albany Med College
Albany, New York, 12208
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Ottawa General Hospital
Ottawa, Ontario,
Canada
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
ViRx / Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Clinsites / Sorra Research Ctr
Birmingham, Alabama, 35203
United States
Oak Lawn Physicians Group
Dallas, Texas, 75219
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555
United States
Additional Information:
Study ID Numbers: 302A; AI424-007
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002240
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
2. Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
3. Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
4. A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults
5. Depot Disulfiram for AIDS and ARC
Related Studies:
Other HIV Infections Clinical Trials
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Other Chicago Clinical Trials
Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs
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