A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, Nevirapine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator. Antifungal prophylaxis with oral fluconazole or ketoconazole. Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir. Dilantin for prevention and treatment of seizures. Patients must have: Asymptomatic HIV infection. CD4 count 200-500 cells/mm3. No prior AIDS. No history of or active HIV-related thrush, vaginal candidiasis, zoster (shingles), excessive weight loss, persistent fever, or diarrhea. Tolerated 500-600 mg AZT daily for at least 4 months but no more than 12 months immediately prior to study entry. Consent of parent or guardian if less than 18 years of age. NOTE: Patients may not co-enroll in another protocol involving other investigational drugs or biologics. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malignancy other than limited cutaneous basal cell carcinoma. Psychiatric condition sufficient to impair study compliance. Concurrent Medication: Excluded: Systemic glucocorticoids and steroid hormones. Dicumarol, warfarin, and other anticoagulant medications. Cimetidine. Tolbutamide. Doxycycline. Chloramphenicol. Phenobarbital and other barbiturates. Foscarnet. Erythromycin. Amoxicillin-clavulanate (Augmentin). Ticarcillin clavulanate. Biologic response modifiers (alpha interferon, IL-2, immune modulators). Any investigational drugs other than study drugs. Patients with the following prior condition are excluded: History of clinically important disease other than HIV infection, that may put patient at risk because of participation in this study. Prior Medication: Excluded: Antiretroviral medications other than AZT. Excluded within 4 weeks prior to study entry: Immunosuppressive or cytotoxic drugs or other experimental drugs. Systemic glucocorticoids and steroid hormones. Dicumarol, warfarin, and other anticoagulant medications. Cimetidine. Tolbutamide. Doxycycline. Chloramphenicol. Phenobarbital and other barbiturates. Foscarnet. Erythromycin. Amoxicillin-clavulanate (augmentin). Ticarcillin clavulanate. Biologic response modifiers (alpha interferon, IL-2, immune modulators). Required: AZT at 500-600 mg/day for at least 4 months but no more than 12 months immediately preceding study entry. Chronic use of alcohol or drugs sufficient to impair study compliance.
Sites / Locations
- Highland Gen Hosp / San Francisco Gen Hosp
- Northwestern Univ Med School
- Johns Hopkins Hosp
- Washington Univ School of Medicine
- Univ TX Galveston Med Branch