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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000747
First received: November 2, 1999
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nevirapine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 10
Primary Completion Date: December 1994 (Final data collection date for primary outcome measure)
Detailed Description:

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.

Ten patients receive nevirapine daily for 12 weeks. After 12 weeks of therapy, patients in whom resistance was not evident at week 4 and who have an adequate safety profile continue receiving nevirapine for an additional 12 weeks. Clinical and immunological assessments are performed at weeks 4, 8, 12, 16, 20, and 24. Virological assessments are performed at week 24 only. If 50 percent of patients develop resistance at any time, the study is discontinued.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Excluded 4 hours before or after a nevirapine dose:

  • Antacids (particularly those containing calcium carbonate).
  • H-2 blockers, carafate, cholestyramine resin, alcohol and alcohol-containing substances, and benzodiazepines (e.g., diazepam, triazolam).

Patients with the following prior conditions are excluded:

  • History of clinically important disease other than HIV infection.

Prior Medication:

Excluded within 1 month prior to study entry:

  • Any immunosuppressive, immunomodulatory, or cytotoxic treatment.

Use of drugs or alcohol sufficient to impair compliance with protocol requirements.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000747

Locations
United States, California
UCSD
San Diego, California, United States, 92103
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Richman D
  More Information

Additional Information:
Publications:
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)

ClinicalTrials.gov Identifier: NCT00000747     History of Changes
Other Study ID Numbers: ACTG 208, BI 00947
Study First Received: November 2, 1999
Last Updated: February 28, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Resistance
AIDS-Related Complex
Antiviral Agents
Nevirapine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014