A Study of Viracept in HIV-Positive Women

A Phase II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Viracept in Combination With Antiretroviral Therapy in HIV Positive Women With <= 1 Month of Prior Treatment With d4T and/or 3TC

The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count <= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.

Inclusion Criteria

Patients must have:

• HIV infection.
• CD4 T cell count <= 400 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

• Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
• Prior protease inhibitor therapy.