Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Boehringer Ingelheim

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 e...

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 ...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00000747

Last Update

March 1 2011

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

UCSD

San Diego, California, United States, 92103