A Study of Efavirenz in Combination With Stavudine and Didanosine

Study Overview
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Brief Summary
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The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.

Detailed Description
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Patients will be given combination treatment with efavirenz, stavudine, and didanosine.

Official Title
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A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Didanosine in Antiretroviral Therapy-Naive HIV-Infected Patients

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Efavirenz
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml. A life expectancy of at least 12 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current bilateral peripheral neuropathy greater than or equal to Grade 2. Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values). Any clinically significant disease (other than HIV infection) or clinically significant findings during screening of medical history or physical examination. Any malignancy that requires systemic therapy. Proven or suspected acute hepatitis due to any cause. Recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4 days within 3 months prior to dosing. Active AIDS-defining opportunistic infection or disease. Concurrent Medication: Excluded: Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. Life expectancy less than 12 months. Difficulty in swallowing capsules/tablets. Hypersensitivity to any component of the formulation of efavirenz, stavudine, or didanosine. Prior Medication: Excluded: Any other experimental drug within 30 days of introducing study treatment. Vaccination within 3 weeks of screening visit. Interferon started within 30 days of initiating study treatment. Prior antiretroviral therapy. Risk Behavior: Excluded: - Current alcohol or illicit drug use which would interfere with compliance with dosing schedule and protocol evaluations.

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: Efavirenz|nan|
|Drug: Stavudine|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, Stavudine, Reverse Transcriptase Inhibitors, efavirenz