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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nevirapine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Nevirapine, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boehringer Ingelheim Pharmaceuticals Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00002166
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Nevirapine, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Boehringer Ingelheim Pharmaceuticals Inc
City
Ridgefield
State/Province
Connecticut
ZIP/Postal Code
06877
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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