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Home > "A" Clinical Trials Conditions > A Study of Efavirenz in Combination with Stavudine and Didanosine  A Study of Efavirenz in Combination with Stavudine and Didanosine
A Study of Efavirenz in Combination with Stavudine and Didanosine
For Condition: HIV Infections
Status: Completed
Sponsor(s): Dupont Merck ,
Synopsis: 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.
Details: Patients will be given combination treatment with efavirenz, stavudine, and didanosine.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
North Shore AIDS Hosp / Division of Infectious Disease
Manhasset, New York, 11030
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Carolinas Research Associates
Charlotte, North Carolina, 28207
United States
The Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: 281D; DMP 266-044
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002225
Other Hiv Infections Studies:
1. Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
2. A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
3. A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
4. A Study of Patients Who Recently Have Been Infected with HIV
5. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
Related Studies:
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A Study of Efavirenz in Combination with Stavudine and Didanosine
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