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Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atazanavir
Nelfinavir mesylate
Stavudine
Didanosine
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 Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir

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 an HIV blood level between 2,000 and 200,000 copies/ml. Have a CD4 cell count of at least 100 cells/mm3. Are 18 years of age or older. Are available for follow-up for at least 48 weeks. Agree to use a barrier method of birth control (such as condoms) during the study. Exclusion Criteria Patients will not be eligible for this study if they: Have ever received anti-HIV (antiretroviral) treatment. Have an HIV-related opportunistic infection or condition at the time of study entry. Have primary HIV infection, meaning they have recently been infected. Have had severe diarrhea within the 30 days before study entry. Have hemophilia. Have a history of pancreatitis, hepatitis, or a peripheral neuropathy. Are unable to tolerate oral medication. Are pregnant or breast-feeding. Abuse alcohol or drugs.

Sites / Locations

  • Clinsites / Sorra Research Ctr
  • Univ of Alabama at Birmingham
  • UCSD Treatment Ctr
  • UCSF - San Francisco Gen Hosp
  • Univ of Colorado / Health Science Ctr
  • ViRx / Dupont Circle Physicians Group
  • AIDS Research Consortium of Atlanta
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Washington Univ School of Medicine
  • Albany Med College
  • Beth Israel Med Ctr
  • Columbia Presbyterian Med Ctr
  • Case Western Reserve Univ
  • Oak Lawn Physicians Group
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Univ TX Galveston Med Branch
  • Ottawa General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 28, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002240
Brief Title
Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs
Official Title
Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (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 evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.
Detailed Description
Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

6. Conditions and Keywords

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

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)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

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 an HIV blood level between 2,000 and 200,000 copies/ml. Have a CD4 cell count of at least 100 cells/mm3. Are 18 years of age or older. Are available for follow-up for at least 48 weeks. Agree to use a barrier method of birth control (such as condoms) during the study. Exclusion Criteria Patients will not be eligible for this study if they: Have ever received anti-HIV (antiretroviral) treatment. Have an HIV-related opportunistic infection or condition at the time of study entry. Have primary HIV infection, meaning they have recently been infected. Have had severe diarrhea within the 30 days before study entry. Have hemophilia. Have a history of pancreatitis, hepatitis, or a peripheral neuropathy. Are unable to tolerate oral medication. Are pregnant or breast-feeding. Abuse alcohol or drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Clinsites / Sorra Research Ctr
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCSD Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
ViRx / Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Washington Univ School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oak Lawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
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
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
Piliero P, et al. AI424-007: Atazanavir: an HIV protease inhibitor (PI) that does not cause lipid elevations. International Symposium on Drugs Affecting Lipid Metabolism. 2001 Sept 9 - 12
Results Reference
background
Citation
Gatell JM, et al. AI424-007: Atazanavir (BMS-232632): Absence of serum lipid changes after 48 weeks of treatment in treatment-naive HIV-positive subjects (Trial AI424007). 8th European Conf on Clinical Aspects and Treatment of HIV Infection (8th ECCATHI). 2001 Oct 28 - 31 (abstract no 223)
Results Reference
background
Citation
Piliero P, et al. AI424-007: BMS-232632 - Clinical Trial AI424007: Safety, Efficacy of a Once-Daily Protease Inhibitor at 24 Weeks. 5th International Congress on Drug Therapy in HIV Infection. 2000 Octr 22 - 26
Results Reference
background
Citation
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Novel Once-Daily HIV-1 Protease Inhibitor BMS-232632: Preliminary Results from a Phase II Clinical Trial. 7th Conf Retroviruses and Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 672)
Results Reference
background
Citation
Squires K, Gatell J, Piliero P, Sanne I, Wood R, Schnittman SM. AI424-007: 48-week safety and efficacy results from a phase II study of a once-daily HIV-1 protease inhibitor (PI), BMS-232632. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 15)
Results Reference
background
Citation
Sanne I, Piliero P, Wood R, Kelleher T, Cross A, Mongillo A, Schnittman S. AI424-007: Safety and Antiviral Efficacy of a Once-Daily HIV-1 Protease Inhibitor BMS-232632: 24 Week Results from a Phase II Clinical Trial. 40th Interscience Conf on Antimicrobial Agents and Chemotherapy. 2000 September 17-20 (abstract no 691)
Results Reference
background
Citation
Piliero P, Cahn P, Pantaleo G, Gatell JM, Squires K, Percival L, Sanne I, Wood R, Phanuphak P, Shelton S, Lazzarin A, Thiry A, Kelleher T, Giordano M, Schnittman SM. AI424-007: Atazanavir: A Once-Daily Protease Inhibitor with a Superior Lipid Profile-Results of Clinical Trials Beyond Week 48. 9th Conf on Retroviruses and Opportunistic Infect. 2002 Feb 24 - 28 (abstract no 706-T)
Results Reference
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Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

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