To provide access to Viramune and to evaluate the tolerance and safety of Viramune in
patients with progressive, symptomatic HIV disease who failed or are intolerant to currently
approved treatment for HIV-1 infection and who are unable to participate in another Viramune
controlled clinical trial and have a compelling need for anti-HIV treatment.
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
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
- Patient or guardian is willing and able to follow protocol requirements. (PER
- Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be
Patients with the following symptoms and conditions are excluded:
Patient qualifies for participation in an actively accruing Viramune controlled clinical
- Dicumarol, Warfarin, and other anticoagulant medications.
- Investigational drugs, all protease inhibitors, and all other non-nucleoside
- Neurotoxic drugs.
Patient has failed or is intolerant to currently approved treatments for HIV-1 infection.