Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

June 23, 2005 updated by: GlaxoSmithKline

A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.

An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Body Positive
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Health for Life Clinic
    • California
      • Fountain Valley, California, United States, 92708
        • Orange County Ctr for Special Immunology
      • San Francisco, California, United States, 94115
        • Pacific Horizons Med Group
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Beacon Clinic / Boulder Community Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Infectious Disease Consultants
      • Fort Lauderdale, Florida, United States, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Miami, Florida, United States, 33136
        • Univ of Miami / Jackson Memorial Hosp
      • Miami Beach, Florida, United States, 33140
        • SBMA Research
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Gen Hosp / Division of Infect Diseases
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville / ID Division
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • HIV Outpatient Clinics / LA State Univ Med Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Med Ctr
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Dr Paul Benson
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Med Ctr
      • St. Paul, Minnesota, United States, 55101
        • Regions Hosp / HIV/AIDS Program
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • CRC of Mississippi
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Wellness Ctr / Las Vegas
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Newark, New Jersey, United States, 07103
        • NJCRI
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY / Health Sciences Ctr at Brooklyn
      • New York, New York, United States, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • ID Consultants
      • Greenville, North Carolina, United States, 27858
        • East Carolina Univ School of Medicine
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Univ of Oklahoma Infectious Disease Institute
      • Tulsa, Oklahoma, United States, 74114
        • Associates in Med and Mental Health
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Univ of Tennessee Med Ctr at Knoxville
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech Health Sciences Ctr
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infectious Diseases Associates
      • Fort Worth, Texas, United States, 76104
        • AIDS Outreach Center
      • Fort Worth, Texas, United States, 76104
        • Metroplex Infectious Disease
      • Houston, Texas, United States, 77027
        • Diversified Med Practices, PA
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts
      • Houston, Texas, United States, 77030
        • Infectious Diseases Associates of Houston
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Infectious Disease Physicians Inc
      • Fairfax, Virginia, United States, 22030
        • Infectious Disease Consultants
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 13 years old.
  • Are HIV-positive.
  • Have a viral load of at least 5,000 copies/ml.
  • Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.
  • Provide written consent of a parent or guardian, if under 18 years of age.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken nonnucleoside reverse transcriptase inhibitors.
  • Have taken other anti-HIV drugs for 2 weeks or more.
  • Have an opportunistic (AIDS-related) infection.
  • Are pregnant or breast-feeding.
  • Have had hepatitis within the past 6 months.
  • Are allergic to the study drugs or their ingredients.
  • Have a mental, physical, or substance abuse disorder.
  • Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
  • Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth.
  • Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons).
  • Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period.
  • Require foscarnet or other drugs that are shown to be effective against HIV.
  • Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.
  • Are taking experimental drugs.
  • Are unlikely to complete the study or take the drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Registration Dates

First Submitted

March 2, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308B
  • ESS40013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Efavirenz

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe