A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Launched by DUPONT MERCK · Aug 30, 2001

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• • 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.