An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Nevirapine, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility Criteria
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.
Sites / Locations
- Boehringer Ingelheim Pharmaceuticals Inc