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

Launched by BOEHRINGER INGELHEIM · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

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.