An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
- NCT00002166
- PHASE3
- INTERVENTIONAL
Last updated: 2005-06-24
Purpose of Trial
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.
This study is for people with
HIV Infections
Interventions being studied
Nevirapine
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.
ELIGIBILITY
Gender: ALL
Age: 1 Day+
Healthy Volunteers: No
Location
Ridgefield
Boehringer Ingelheim Pharmaceuticals Inc
Connecticut, 06877, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov