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Home > "A" Clinical Trials Conditions > A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs  A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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 lamivudine to patients who have never taken anti-HIV drugs.
Details: Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Richard Elion
Washington D.C., District of Columbia, 20009
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, 29464
United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445
United States
The Milton S Hersey Med Ctr / Div of Hematology
Hershey, Pennsylvania, 170330850
United States
Remington Davis Inc
Columbus, Ohio, 43215
United States
The Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Montrose Clinic
Houston, Texas, 77006
United States
Additional Information:
Study ID Numbers: 281C; DMP 266-043
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002227
Other Hiv Infections Studies:
1. A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
2. Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
3. Preventing Frequent Sinus Infections in HIV-Infected Patients
4. An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium avium-intracellulare Complex Infection (MAC) in Patients with Acquired Immune Deficiency Syndrome (AIDS)
5. A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)
Related Studies:
Other HIV Infections Clinical Trials
Other South Carolina Clinical Trials
Other Mount Pleasant Clinical Trials
A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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