Not Signed In -
Stavudine |
d4T; Zerit |
Clinical Trial: Study of a New Protease Inhibitor, BMS-232632, in Combination with Other Anti-HIV Drugs
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Atazanavir Drug: Nelfinavir mesylate Drug: Stavudine Drug: Didanosine | Phase II |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Safety Study
Official Title: Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination with d4T and ddI as Compared to a Reference Combination Regimen
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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.
Location Information
Alabama
Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States
Clinsites / Sorra Research Ctr, Birmingham, Alabama, 35203, United States
California
UCSF - San Francisco Gen Hosp, San Francisco, California, 94110, United States
UCSD Treatment Ctr, San Diego, California, 92103, United States
Colorado
Univ of Colorado / Health Science Ctr, Denver, Colorado, 80262, United States
District of Columbia
ViRx / Dupont Circle Physicians Group, Washington, District of Columbia, 20009, United States
Georgia
AIDS Research Consortium of Atlanta, Atlanta, Georgia, 30308, United States
Illinois
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States
Missouri
Washington Univ School of Medicine, St. Louis, Missouri, 63108, United States
New York
Beth Israel Med Ctr, New York, New York, 10003, United States
Columbia Presbyterian Med Ctr, New York, New York, 10032, United States
Albany Med College, Albany, New York, 12208, United States
Ohio
Case Western Reserve Univ, Cleveland, Ohio, 44106, United States
Texas
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas, 75235, United States
Oak Lawn Physicians Group, Dallas, Texas, 75219, United States
Univ TX Galveston Med Branch, Galveston, Texas, 77555, United States
Canada, Ontario
Ottawa General Hospital, Ottawa, Ontario, Canada
More Information
Publications
Piliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12
Gatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)
Piliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)
Squires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)
Piliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)
Record last reviewed: April 2002
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002240
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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