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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
Official Title ^ICMJE	An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
Brief 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.
Detailed 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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Parallel Assignment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Nevirapine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002166
Responsible Party
Study ID Numbers ^ICMJE	200D, 1100.859
Study Sponsor ^ICMJE	Boehringer Ingelheim Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP