Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
HIV Clinical Research
๐บ๐ธFort Lauderdale, Florida, United States
Infectious Disease Specialists of Atlanta
๐บ๐ธDecatur, Georgia, United States
Albany Med College
๐บ๐ธAlbany, New York, United States
Univ Hosps of Cleveland
๐บ๐ธCleveland, Ohio, United States
Univ of Texas Southwestern Med Ctr of Dallas
๐บ๐ธDallas, Texas, United States
Ottawa General Hospital
๐จ๐ฆOttawa, Ontario, Canada
Toronto Hosp
๐จ๐ฆToronto, Ontario, Canada
Houston Clinical Research Network / Div of Montrose Clinic
๐บ๐ธHouston, Texas, United States
Yale Univ School of Medicine / AIDS Program
๐บ๐ธNew Haven, Connecticut, United States
Julio Arroyo
๐บ๐ธWest Columbia, South Carolina, United States
Montreal Chest Institute
๐จ๐ฆMontreal, Quebec, Canada
Vanderbilt Univ Med Ctr
๐บ๐ธNashville, Tennessee, United States
Reparto Malattie Infettive
๐ฎ๐นAntella, Italy
Ospedale Luigi Cacco Moroni
๐ฎ๐นMilano, Italy
Sorra Research Ctr / Med Forum
๐บ๐ธBirmingham, Alabama, United States
The Research and Education Group
๐บ๐ธPortland, Oregon, United States
Robert Scott MD
๐บ๐ธOakland, California, United States
Community Research Initiative of South Florida
๐บ๐ธCoral Gables, Florida, United States
Univ of California - Davis Med Ctr / CARES
๐บ๐ธSacramento, California, United States
Avalar Medical Group
๐บ๐ธTarzana, California, United States
Infectious Disease Research Institute
๐บ๐ธTampa, Florida, United States
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
๐บ๐ธNew Orleans, Louisiana, United States
St Vincents Hosp / Clinical Research Program
๐บ๐ธNew York, New York, United States
Texas Tech Health Sciences Ctr
๐บ๐ธEl Paso, Texas, United States
Hopital De L'Hotel Dieu
๐ซ๐ทNantes, France
Hopital Pellegrin Tripode
๐ซ๐ทBordeaux, France
Hopital Paul Brousse
๐ซ๐ทVillejuif, France
Hopital De L'Archet 1
๐ซ๐ทNice, France
Srev Du Pr Gentilini
๐ซ๐ทParis Cedex 13, France
Brennerstr 71
๐ฉ๐ชHamburg, Germany
Hopital De Haut Leveque
๐ซ๐ทPessac, France
Hospital Gustave Dron
๐ซ๐ทTourcoing, France
Georg-Str 46
๐ฉ๐ชHanover, Germany
Clinical Malattie Infettive
๐ฎ๐นMilano, Italy
Praxisgemeinschaft
๐ฉ๐ชMunich, Germany
Clinical Malattie Infettive / Univ Modena
๐ฎ๐นModena, Italy
Ospedale degli Infermi
๐ฎ๐นRimini, Italy
AIDS Healthcare Foundation
๐บ๐ธLos Angeles, California, United States