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A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Stavudine
Zidovudine
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 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

  • Univ of Alabama at Birmingham
  • HIV Clinical Research Ctr
  • Infectious Disease Research Institute Inc
  • Advance Clinical Research
  • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
  • Boston Univ Med Ctr Hosp / Evans - 556
  • Community Research Initiative of New England
  • Washington Univ School of Medicine
  • Blackstock Family Health Ctr
  • Hosp Regional de Ponce - Area Vieja
  • San Juan AIDS Program

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
NCT00002369
Brief Title
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/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
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
Detailed Description
100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + 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
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

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
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
HIV Clinical Research Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Advance Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
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
Boston Univ Med Ctr Hosp / Evans - 556
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Community Research Initiative of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
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
Blackstock Family Health Ctr
City
Austin
State/Province
Texas
ZIP/Postal Code
76751
Country
United States
Facility Name
Hosp Regional de Ponce - Area Vieja
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
San Juan AIDS Program
City
Santurce
ZIP/Postal Code
00908
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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