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

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00004584
Lead Sponsor
Bristol-Myers Squibb
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (38)

HIV Clinical Research

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Fort Lauderdale, Florida, United States

Infectious Disease Specialists of Atlanta

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Decatur, Georgia, United States

Albany Med College

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Albany, New York, United States

Univ Hosps of Cleveland

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Cleveland, Ohio, United States

Univ of Texas Southwestern Med Ctr of Dallas

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Dallas, Texas, United States

Ottawa General Hospital

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Ottawa, Ontario, Canada

Toronto Hosp

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Toronto, Ontario, Canada

Houston Clinical Research Network / Div of Montrose Clinic

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Houston, Texas, United States

Yale Univ School of Medicine / AIDS Program

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New Haven, Connecticut, United States

Julio Arroyo

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West Columbia, South Carolina, United States

Montreal Chest Institute

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Montreal, Quebec, Canada

Vanderbilt Univ Med Ctr

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Nashville, Tennessee, United States

Reparto Malattie Infettive

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Antella, Italy

Ospedale Luigi Cacco Moroni

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Milano, Italy

Sorra Research Ctr / Med Forum

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Birmingham, Alabama, United States

The Research and Education Group

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Portland, Oregon, United States

Robert Scott MD

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Oakland, California, United States

Community Research Initiative of South Florida

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Coral Gables, Florida, United States

Univ of California - Davis Med Ctr / CARES

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Sacramento, California, United States

Avalar Medical Group

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Tarzana, California, United States

Infectious Disease Research Institute

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Tampa, Florida, United States

Louisiana State Univ Med Ctr / HIV Outpatient Clinic

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New Orleans, Louisiana, United States

St Vincents Hosp / Clinical Research Program

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New York, New York, United States

Texas Tech Health Sciences Ctr

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El Paso, Texas, United States

Hopital De L'Hotel Dieu

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Nantes, France

Hopital Pellegrin Tripode

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Bordeaux, France

Hopital Paul Brousse

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Villejuif, France

Hopital De L'Archet 1

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Nice, France

Srev Du Pr Gentilini

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Paris Cedex 13, France

Brennerstr 71

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Hamburg, Germany

Hopital De Haut Leveque

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Pessac, France

Hospital Gustave Dron

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Tourcoing, France

Georg-Str 46

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Hanover, Germany

Clinical Malattie Infettive

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Milano, Italy

Praxisgemeinschaft

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Munich, Germany

Clinical Malattie Infettive / Univ Modena

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Modena, Italy

Ospedale degli Infermi

๐Ÿ‡ฎ๐Ÿ‡น

Rimini, Italy

AIDS Healthcare Foundation

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Los Angeles, California, United States

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