Clinical trial NCT00002240: Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Didanosine
Dose-Response Relationship, Drug
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinsites / Sorra Research Ctr
state: Alabama
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: UCSD Treatment Ctr
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Denver
country: United States
facility: Univ of Colorado / Health Science Ctr
state: Colorado
city: Washington
country: United States
facility: ViRx / Dupont Circle Physicians Group
state: District of Columbia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: St Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Med College
state: New York
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Dallas
country: United States
facility: Oak Lawn Physicians Group
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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)
citation: 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
citation: 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)
citation: 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)
citation: 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)
citation: 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)