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
Completed · Phase 2
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000747
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 10
- Last updated by the study team
- 2011-03-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCSD — San Diego, California, United States
Full record on ClinicalTrials.gov
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