A Study of Efavirenz in Combination With Stavudine and Didanosine

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

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.

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

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.