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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 Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002166
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Completed
Phase Phase 3
View Details
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