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

Bristol-Myers Squibb200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

200

Conditions

HIV Infections

Interventions

Indinavir sulfateDRUG

LamivudineDRUG

StavudineDRUG

ZidovudineDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (11)

Univ of Alabama at Birmingham

Birmingham, Alabama, United States

HIV Clinical Research Ctr

Fort Lauderdale, Florida, United States

Infectious Disease Research Institute Inc

Tampa, Florida, United States

Data from ClinicalTrials.gov

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