An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3

NCT00000747 | Completed Phase 2

• 2 other identifiers: ACTG 208BI 00947
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3. Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts \<= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.

Conditions

HIV Infections

Keywords

Drug Resistance; AIDS-Related Complex; Antiviral Agents; Nevirapine

Interventions

Nevirapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have:
• Positive serum antibody to HIV-1 by ELISA or Western blot.
• CD4 count \>= 500 cells/mm3 within 2 months prior to study entry, with two additional counts averaging \>= 450 cells/mm3 at baseline and on study day 0 (taken at least 48 hours apart).
• No AIDS-defining disease.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• More than four loose stools per day.
• Participation in other experimental trials including vaccine trials.
• Concurrent Medication:
• Excluded:
• Other approved or investigational antiretroviral agents, other investigational agents, or vaccines.
• Glucocorticoids and steroid hormones.
• Dicumarol, warfarin, and other anticoagulants.
• Digitoxin.
• Valproic acid.
• Tolbutamide.
• Doxycycline.
• Chloramphenicol.
• Phenobarbital and other barbiturates.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

UCSD

San Diego, California, 92103, United States

Location

Related Publications (2)

• Havlir D. An open-label pilot study to evaluate the development of resistance to nevirapine (BI-RG-587) in HIV-infected patients with CD4 cell count > or = 500/mm. ACTG 208 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):470 (abstract no PO-B26-2009)

  BACKGROUND

• Havlir D, McLaughlin MM, Richman DD. A pilot study to evaluate the development of resistance to nevirapine in asymptomatic human immunodeficiency virus-infected patients with CD4 cell counts of > 500/mm3: AIDS Clinical Trials Group Protocol 208. J Infect Dis. 1995 Nov;172(5):1379-83. doi: 10.1093/infdis/172.5.1379.

  PMID: 7594683 BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Related Complex

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richman D

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: December 1, 1994
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

US (1)