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 Month

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.

SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nevirapine; Zidovudine

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.