A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Efavirenz (Drug); Lamivudine (Drug); Stavudine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dupont Merck
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.
Clinical Details
Official title: 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
Study design: Treatment, Safety Study
Detailed description:
Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Richard Elion, Washington, District of Columbia 20009, United States
The Whitman Walker Clinic, Washington, 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, Mount Pleasant, South Carolina 29464, United States
Montrose Clinic, Houston, Texas 77006, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Additional Information
Last updated: June 23, 2005
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