A Study of Efavirenz in Combination With Stavudine and Didanosine

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002225

Run by

Dupont Merck

People needed

60

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• The Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• North Shore AIDS Hosp / Division of Infectious Disease — Manhassett, New York, United States
• Univ of Rochester Med Ctr — Rochester, New York, United States
• Carolinas Research Associates — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.