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 Details — Status: Completed

Administrative data

• NCT number: NCT00002166
• Other study ID #: 200D
• Secondary ID: 1100.859
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine

Locations

Country	Name	City	State
United States	Boehringer Ingelheim Pharmaceuticals Inc	Ridgefield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States,