A Study of Efavirenz in Combination With Stavudine and Didanosine
NCT ID: NCT00002225
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
Stavudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Dupont Merck
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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DMP 266-044
Identifier Type: -
Identifier Source: secondary_id
281D
Identifier Type: -
Identifier Source: org_study_id