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)
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1
UCSD
San Diego, California, United States, 92103