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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Stavudine; Drug: Indinavir sulfate; Drug: Lamivudine; Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002369

260A

BMS 001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.