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A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Stavudine
Zidovudine
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, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

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

Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.

Sites / Locations

  • East Bay AIDS Clinic
  • Harbor UCLA Med Ctr / Division of Immunology / N-24
  • Anderson Clinical Research
  • George Washington Med Ctr / Clinical Trials Unit
  • Chicago Ctr for Clinical Research
  • Northwestern Univ
  • Univ of Nebraska
  • Univ of North Carolina / Infectious Disease Division
  • The Nalle Clinic / Clinical Research Dept
  • Univ of Pennsylvania / Infectious Diseases Division
  • Southwest Infectious Disease Association / PA
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Hosp Regional de Ponce - Area Vieja

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 1, 2007
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002168
Brief Title
A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
Official Title
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
Detailed Description
100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated 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, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.
Facility Information:
Facility Name
East Bay AIDS Clinic
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Harbor UCLA Med Ctr / Division of Immunology / N-24
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Anderson Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
George Washington Med Ctr / Clinical Trials Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Northwestern Univ
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Univ of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68195
Country
United States
Facility Name
Univ of North Carolina / Infectious Disease Division
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Nalle Clinic / Clinical Research Dept
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Univ of Pennsylvania / Infectious Diseases Division
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Southwest Infectious Disease Association / PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
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
Hosp Regional de Ponce - Area Vieja
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico

12. IPD Sharing Statement

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A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

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