Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment

HIV Infections Clinical Trial

Official title:

Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004584
• Other study ID #: 302B
• Secondary ID: AI424-009
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2000
• Last updated: April 28, 2011
• Start date: December 1999
• Est. completion date: January 2002

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.

Description:

This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2002
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have a viral load (level of HIV in the blood) of at least 2,000 copies/ml.

• Have a CD4 count of at least 100 cells/mm3 (or at least 75 cells/mm3 in patients who have never had an AIDS-defining illness).

• Are currently receiving an anti-HIV drug combination that includes a protease inhibitor or nonnucleoside reverse transcriptase inhibitor (NNRTI), and they have been taking this drug combination for at least 24 weeks. They must have responded well to this treatment at first (their viral load decreased) but are currently experiencing an increase in viral load.

• Will most likely respond well to the study drugs, as shown by the results of a lab test.

• Are at least 18 years old.

• Agree to use effective barrier methods of birth control (such as condoms).

• Are available for follow-up for at least 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have a newly diagnosed opportunistic (HIV-related) infection requiring treatment.

• Have only recently become HIV positive.

• Abuse alcohol or drugs.

• Have severe diarrhea within 30 days of study entry.

• Have hemophilia.

• Have a history of pancreatitis.

• Have hepatitis within 30 days of study entry.

• Have peripheral neuropathy (a painful condition affecting the nervous system).

• Are unable to take medications by mouth.

• Are pregnant or breast-feeding.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir

• Ritonavir

• Saquinavir

Locations

Country	Name	City	State
Canada	Montreal Chest Institute	Montreal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Toronto Hosp	Toronto	Ontario
France	Hopital Pellegrin Tripode	Bordeaux
France	Hopital De L'Hotel Dieu	Nantes
France	Hopital De L'Archet 1	Nice
France	Srev Du Pr Gentilini	Paris Cedex 13
France	Hopital De Haut Leveque	Pessac
France	Hospital Gustave Dron	Tourcoing
France	Hopital Paul Brousse	Villejuif
Germany	Brennerstr 71	Hamburg
Germany	Georg-Str 46	Hanover
Germany	Praxisgemeinschaft	Munich
Italy	Reparto Malattie Infettive	Antella
Italy	Clinical Malattie Infettive	Milano
Italy	Ospedale Luigi Cacco Moroni	Milano
Italy	Clinical Malattie Infettive / Univ Modena	Modena
Italy	Ospedale degli Infermi	Rimini
United States	Albany Med College	Albany	New York
United States	Sorra Research Ctr / Med Forum	Birmingham	Alabama
United States	Univ Hosps of Cleveland	Cleveland	Ohio
United States	Community Research Initiative of South Florida	Coral Gables	Florida
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	Texas Tech Health Sciences Ctr	El Paso	Texas
United States	HIV Clinical Research	Fort Lauderdale	Florida
United States	Houston Clinical Research Network / Div of Montrose Clinic	Houston	Texas
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Yale Univ School of Medicine / AIDS Program	New Haven	Connecticut
United States	Louisiana State Univ Med Ctr / HIV Outpatient Clinic	New Orleans	Louisiana
United States	St Vincents Hosp / Clinical Research Program	New York	New York
United States	Robert Scott MD	Oakland	California
United States	The Research and Education Group	Portland	Oregon
United States	Univ of California - Davis Med Ctr / CARES	Sacramento	California
United States	Infectious Disease Research Institute	Tampa	Florida
United States	Avalar Medical Group	Tarzana	California
United States	Julio Arroyo	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy, 

References & Publications (2)

Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424-009: Once-Daily Atazanavir plus Saquinavir favorably affects total cholesterol and fasting triglycerides in patients failing prior PI therapy study BMS-009,week 24. 41st Annual Conf on Antimicrobial Agents and Chemotherapy. 2001 Feb 16-19 (abstract no LB-16)

Haas DW, Zala C, Schrader S,Thiry A, McGovern R, Schnittman S. AI424009: Atazanavir plus Saquinavir once daily favorably affects total cholesterol (TC), fasting triglyceride (TG), and fasting LDL cholesterol (LDL) profiles in patients failing prior therapy week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24-28 (abstract no 42)

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm