HIV Infections
Conditions
Keywords
Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, efavirenz
Brief summary
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
Patients will be given combination treatment with efavirenz, stavudine, and didanosine.
Interventions
DRUGEfavirenz
DRUGStavudine
DRUGDidanosine
Sponsors
Dupont Merck
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed