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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002168

260B

BMS 002

Details and patient eligibility

About

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.

Full 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.

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.