An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease

Eligible adult patients (>= 13 years of age) will receive treatment with Viramune once daily for 2 weeks and then twice daily. Eligible pediatric patients (< 13 years of age) will receive a lower dose of Viramune once daily for 2 weeks and then twice daily. All patients will receive Viramune with or without concomitant antiretroviral therapy. Patients will be evaluated at weeks 2, 4, 8, 16, 24, 32 and every 8 weeks thereafter.

PER AMENDMENT 01/31/97: Enrollment closed to adult patients. As of 1/31/97 only enrolling pediatric patients.

Inclusion criteria

Patients must have:

• Patients > 18 months of age with history of positive serology for HIV-1 infection or patients <= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture.
• Patients >= 13 years of age with a CD4+ cell count <= 200 cells/mm3. Patients < 13 years of age with a CD4% <= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was >=20%.
• Patient has failed or is intolerant to currently approved treatments for HIV-1 infection and is unable to participate in a controlled viramune clinical trial.
• Written and informed consent from a parent or guardian for patients < 18 years of age.
• Patient or guardian is willing and able to follow protocol requirements. (PER AMENDMENT 1/29/97:
• Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled.)

Exclusion criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Patient qualifies for participation in an actively accruing Viramune controlled clinical trial.

Concurrent Medication:

Excluded:

• Dicumarol, Warfarin, and other anticoagulant medications.
• Tolbutamide.
• Investigational drugs, all protease inhibitors, and all other non-nucleoside transcriptase inhibitors.
• Neurotoxic drugs.
• Cimetidine.
• Erythromycin.

Required:

Patient has failed or is intolerant to currently approved treatments for HIV-1 infection.