A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
NCT ID: NCT00002227
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Efavirenz
Lamivudine
Stavudine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Dupont Merck
INDUSTRY
Locations
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Richard Elion
Washington D.C., District of Columbia, United States
The Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Community Research Initiative of New England
Brookline, Massachusetts, United States
Remington Davis Inc
Columbus, Ohio, United States
The Milton S Hersey Med Ctr / Div of Hematology
Hershey, Pennsylvania, United States
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, United States
Montrose Clinic
Houston, Texas, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Countries
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Other Identifiers
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DMP 266-043
Identifier Type: -
Identifier Source: secondary_id
281C
Identifier Type: -
Identifier Source: org_study_id