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NCT00002369 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002369
Other study ID # 260A
Secondary ID BMS 001
Status Completed
Phase N/A
First received November 2, 1999
Last updated October 1, 2007

Study information
Verified date October 2007
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Lamivudine

• Stavudine

• Zidovudine

Locations
Country Name City State
Puerto Rico Hosp Regional de Ponce - Area Vieja Ponce
Puerto Rico San Juan AIDS Program Santurce
United States Advance Clinical Research Atlanta Georgia
United States Blackstock Family Health Ctr Austin Texas
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Boston Univ Med Ctr Hosp / Evans - 556 Boston Massachusetts
United States Community Research Initiative of New England Brookline Massachusetts
United States HIV Clinical Research Ctr Fort Lauderdale Florida
United States Louisiana State Univ Med Ctr / HIV Outpatient Clinic New Orleans Louisiana
United States Washington Univ School of Medicine St Louis Missouri
United States Infectious Disease Research Institute Inc Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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