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

Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.

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.