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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Boehringer Ingelheim
• Treatments: Nevirapine

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.