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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 con...

Gender

ALL

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.