An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3

Inclusion Criteria

Patients must have:

• Positive serum antibody to HIV-1 by ELISA or Western blot.
• CD4 count >= 500 cells/mm3 within 2 months prior to study entry, with two additional counts averaging >= 450 cells/mm3 at baseline and on study day 0 (taken at least 48 hours apart).
• No AIDS-defining disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• More than four loose stools per day.
• Participation in other experimental trials including vaccine trials.

Concurrent Medication:

Excluded:

• Other approved or investigational antiretroviral agents, other investigational agents, or vaccines.
• Glucocorticoids and steroid hormones.
• Dicumarol, warfarin, and other anticoagulants.
• Digitoxin.
• Valproic acid.
• Tolbutamide.
• Doxycycline.
• Chloramphenicol.
• Phenobarbital and other barbiturates.

Excluded 4 hours before or after a nevirapine dose:

• Antacids (particularly those containing calcium carbonate).
• H-2 blockers, carafate, cholestyramine resin, alcohol and alcohol-containing substances, and benzodiazepines (e.g., diazepam, triazolam).

Patients with the following prior conditions are excluded:

• History of clinically important disease other than HIV infection.

Prior Medication:

Excluded within 1 month prior to study entry:

• Any immunosuppressive, immunomodulatory, or cytotoxic treatment.

Use of drugs or alcohol sufficient to impair compliance with protocol requirements.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety