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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Nevirapine
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nevirapine|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, Zidovudine, Nevirapine