A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Lamivudine in Antiretroviral Therapy-Naive HIV-Infected Patients
2 other identifiers
interventional
60
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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.
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dupont Mercklead
Study Sites (8)
Richard Elion
Washington D.C., District of Columbia, 20009, United States
The Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445, United States
Remington Davis Inc
Columbus, Ohio, 43215, United States
The Milton S Hersey Med Ctr / Div of Hematology
Hershey, Pennsylvania, 170330850, United States
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, 29464, United States
Montrose Clinic
Houston, Texas, 77006, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-11