Clinical trial NCT00004584: Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Dose-Response Relationship, Drug
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
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 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.

Detailed 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.

Eligibility criteria: 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.

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