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

Launched by BOEHRINGER INGELHEIM · Aug 30, 2001

Keywords

ClinConnect Summary

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

Gender

ALL

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.