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A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs | Clinical Trials | Clareo Health

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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

NCT00002227•Dupont Merck

View on ClinicalTrials.gov

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.

Detailed Description

Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.

Eligibility

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

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.
+17 more criteria

Locations (8)

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

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Efavirenz

DRUG

Lamivudine

DRUG

Stavudine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Inclusion Criteria

Exclusion Criteria

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