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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00004584

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanavir Drug: Ritonavir Drug: Saquinavir	Phase II

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Saquinavir Saquinavir mesylate Ritonavir BMS 232632 Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004584

Hide Study Locations

Locations

United States, Alabama
Sorra Research Ctr / Med Forum
Birmingham, Alabama, United States, 35203
United States, California
Robert Scott MD
Oakland, California, United States, 94609
Univ of California - Davis Med Ctr / CARES
Sacramento, California, United States, 95817
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Avalar Medical Group
Tarzana, California, United States, 91356
United States, Connecticut
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, United States, 06510
United States, Florida
Community Research Initiative of South Florida
Coral Gables, Florida, United States, 33146
HIV Clinical Research
Fort Lauderdale, Florida, United States, 33316
Infectious Disease Research Institute
Tampa, Florida, United States, 33614
United States, Georgia
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
United States, Louisiana
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, United States, 70112
United States, New York
Albany Med College
Albany, New York, United States, 12208
St Vincents Hosp / Clinical Research Program
New York, New York, United States, 10011
United States, Ohio
Univ Hosps of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
The Research and Education Group
Portland, Oregon, United States, 97210
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37212
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Texas Tech Health Sciences Ctr
El Paso, Texas, United States, 79905
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, United States, 77006
Canada, Ontario
Toronto Hosp
Toronto, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada
France
Hopital Paul Brousse
Villejuif, France
Hospital Gustave Dron
Tourcoing, France
Hopital De L'Hotel Dieu
Nantes, France
Hopital De Haut Leveque
Pessac, France
Hopital Pellegrin Tripode
Bordeaux, France
Hopital De L'Archet 1
Nice, France
Srev Du Pr Gentilini
Paris Cedex 13, France
Germany
Brennerstr 71
Hamburg, Germany
Georg-Str 46
Hanover, Germany
Praxisgemeinschaft
Munich, Germany
Italy
Ospedale Luigi Cacco Moroni
Milano, Italy
Clinical Malattie Infettive / Univ Modena
Modena, Italy
Clinical Malattie Infettive
Milano, Italy
Ospedale degli Infermi
Rimini, Italy
Reparto Malattie Infettive
Antella, Italy

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications:

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)

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)

Study ID Numbers:	302B, AI424-009
Study First Received:	February 10, 2000
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00004584 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Dose-Response Relationship, Drug
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir

Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Saquinavir
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents

Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009