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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002227
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Efavirenz
Drug: Lamivudine
Drug: Stavudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 60
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002227

Locations
United States, District of Columbia
Richard Elion
Washington, District of Columbia, United States, 20009
The Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Massachusetts
Community Research Initiative of New England
Brookline, Massachusetts, United States, 02445
United States, Ohio
Remington Davis Inc
Columbus, Ohio, United States, 43215
United States, Pennsylvania
The Milton S Hersey Med Ctr / Div of Hematology
Hershey, Pennsylvania, United States, 170330850
United States, South Carolina
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Montrose Clinic
Houston, Texas, United States, 77006
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Dupont Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002227     History of Changes
Other Study ID Numbers: 281C, DMP 266-043
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
efavirenz

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Lamivudine
Reverse Transcriptase Inhibitors
Stavudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014