Rochester, New York 14642

  • HIV Infections

Purpose:

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.


Study summary:

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


Criteria:

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.


NCT ID:

NCT00002225


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Rochester, New York 14642
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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