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+ Cells/mm3

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.