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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atazanavir
Ritonavir
Saquinavir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dose-Response Relationship, Drug, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sorra Research Ctr / Med Forum
  • AIDS Healthcare Foundation
  • Robert Scott MD
  • Univ of California - Davis Med Ctr / CARES
  • Avalar Medical Group
  • Yale Univ School of Medicine / AIDS Program
  • Community Research Initiative of South Florida
  • HIV Clinical Research
  • Infectious Disease Research Institute
  • Infectious Disease Specialists of Atlanta
  • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
  • Albany Med College
  • St Vincents Hosp / Clinical Research Program
  • Univ Hosps of Cleveland
  • The Research and Education Group
  • Julio Arroyo
  • Vanderbilt Univ Med Ctr
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Texas Tech Health Sciences Ctr
  • Houston Clinical Research Network / Div of Montrose Clinic
  • Ottawa General Hospital
  • Toronto Hosp
  • Montreal Chest Institute
  • Hopital Pellegrin Tripode
  • Hopital De L'Hotel Dieu
  • Hopital De L'Archet 1
  • Srev Du Pr Gentilini
  • Hopital De Haut Leveque
  • Hospital Gustave Dron
  • Hopital Paul Brousse
  • Brennerstr 71
  • Georg-Str 46
  • Praxisgemeinschaft
  • Reparto Malattie Infettive
  • Clinical Malattie Infettive
  • Ospedale Luigi Cacco Moroni
  • Clinical Malattie Infettive / Univ Modena
  • Ospedale degli Infermi

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 10, 2000
Last Updated
April 28, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00004584
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
January 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Dose-Response Relationship, Drug, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atazanavir
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Saquinavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sorra Research Ctr / Med Forum
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Robert Scott MD
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Univ of California - Davis Med Ctr / CARES
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Avalar Medical Group
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Yale Univ School of Medicine / AIDS Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Infectious Disease Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
St Vincents Hosp / Clinical Research Program
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Univ Hosps of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Tech Health Sciences Ctr
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Houston Clinical Research Network / Div of Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital Pellegrin Tripode
City
Bordeaux
Country
France
Facility Name
Hopital De L'Hotel Dieu
City
Nantes
Country
France
Facility Name
Hopital De L'Archet 1
City
Nice
Country
France
Facility Name
Srev Du Pr Gentilini
City
Paris Cedex 13
Country
France
Facility Name
Hopital De Haut Leveque
City
Pessac
Country
France
Facility Name
Hospital Gustave Dron
City
Tourcoing
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
Country
France
Facility Name
Brennerstr 71
City
Hamburg
Country
Germany
Facility Name
Georg-Str 46
City
Hanover
Country
Germany
Facility Name
Praxisgemeinschaft
City
Munich
Country
Germany
Facility Name
Reparto Malattie Infettive
City
Antella
Country
Italy
Facility Name
Clinical Malattie Infettive
City
Milano
Country
Italy
Facility Name
Ospedale Luigi Cacco Moroni
City
Milano
Country
Italy
Facility Name
Clinical Malattie Infettive / Univ Modena
City
Modena
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
Country
Italy

12. IPD Sharing Statement

Citations:
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)
Results Reference
background
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)
Results Reference
background

Learn more about this trial

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

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