The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, AIDS-Related Complex, 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-1 infection, with positive serum antibody to HIV-1 as determined by ELISA or Western blot. CD4 count 200-500 cells/mm3 within 4-28 days prior to study entry. No conditions indicative of AIDS. None of the constitutional symptoms that are specifically excluded. Prior AZT for 3-24 months (amended 04/04/94) immediately prior to study entry (Part I) OR no prior AZT (Part II). Consent of parent or guardian if less than 18 years of age. NOTE: Co-enrollment in a protocol involving another investigational drug or biologic is not permitted. 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 compliance with protocol requirements. Concurrent Medication: Excluded: Investigational drugs other than study 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 (Timentin). Biologic response modifiers (alpha interferon, IL-2, immune modulators). Patients with the following condition are excluded: History of other clinically important disease (i.e., one that precludes participation in the 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 (Timentin). Biologic response modifiers (alpha interferon, IL-2, immune modulators). Required (for patients in Part I): Prior AZT at 500-600 mg daily for at least 3 months but not more than 24 months immediately prior to study entry. Chronic use of alcohol or drugs sufficient to impair compliance with protocol requirements.
Sites / Locations
- UCSD Treatment Ctr
- Saint Francis Mem Hosp
- Wilmington Hosp
- Community Research Initiative of South Florida
- Goodgame Med Group
- Univ of Kansas School of Medicine
- Chandler Med Ctr
- Kansas City AIDS Research Consortium
- Community Research Initiative on AIDS
- Med College of Ohio
- Associates Med and Mental Health
- Philadelphia FIGHT
- Dr Alfred F Burnside Jr
- Nelson-Tebedo Community Clinic
- Houston Clinical Research Network
- Univ of Utah School of Medicine
- Infectious Disease Physicians Inc
- Richmond AIDS Consortium