Inclusion Criteria
Patients must have:
- Documented diagnosis of HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
- 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.
- Proven or suspected acute hepatitis due to any cause.
- Recurrent episodes of moderate to severe diarrhea, or vomiting lasting for more than 4 days within 3 months prior to dosing.
- Hypersensitivity to any component of the formulation of efavirenz, stavudine, or lamivudine.
- 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 found during the screening of medical history or physical examination.
- Any malignancy that requires systemic therapy.
- Any active AIDS-defining opportunistic infection or disease.
Concurrent Medication:
Excluded:
Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine or any medications contraindicated for concomitant use with stavudine or lamivudine as described in the current information package insert.
Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- A life expectancy of less than 12 months.
- Difficulty swallowing capsules/tablets.
- Inability to communicate effectively with study personnel.
Prior Medication:
Excluded:
- Any other experimental drug within 30 days of introducing study treatment.
- Vaccination within 3 weeks of screening visit.
- Any prior antiretroviral therapy.
- Interferon started within 30 days of initiating study treatment.
Risk Behavior:
Excluded:
Current alcohol or illicit drug use which interferes with patient's ability to follow study regimen.
Purpose
