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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002227
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

November 2, 1999
August 31, 2001
June 24, 2005
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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
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.
Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.
Phase 2
Primary Purpose: Treatment
HIV Infections
  • Drug: Efavirenz
  • Drug: Lamivudine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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:


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:


  • 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:


Current alcohol or illicit drug use which interferes with patient's ability to follow study regimen.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
DMP 266-043
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Dupont Merck
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NIH AIDS Clinical Trials Information Service
November 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP