NCT00002166

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2002

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

NevirapineReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

NevirapineDRUG

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Pharmaceuticals Inc

Ridgefield, Connecticut, 06877, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2002-08

Locations

US(1)