A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

Study Overview
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Brief Summary
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To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.

Detailed Description
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The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks. PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.

Official Title
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A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Zidovudine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 count >= 550 cells/mm3. Asymptomatic disease. No prior antiretroviral therapy. Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Medical condition that precludes study compliance. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Biologic response modifiers including erythropoietin and G-CSF. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Systemic radiation therapy. Patients with the following prior conditions are excluded: History of grade 2 or worse peripheral neuropathy. History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: Prior antiretrovirals. Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine|nan|
|Drug: Didanosine|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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Didanosine, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule