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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Efavirenz  Drug: Stavudine  Drug: Didanosine	Phase II

Further Study Details: 

Expected Total Enrollment:  60

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

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

District of Columbia
      The Whitman Walker Clinic, Washington,  District of Columbia,  20009,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
New York
      North Shore AIDS Hosp / Division of Infectious Disease, Manhassett,  New York,  11030,  United States
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States
North Carolina
      Carolinas Research Associates, Charlotte,  North Carolina,  28207,  United States

Study ID Numbers:  281D; DMP 266-044
Record last reviewed:  November 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002225
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08