Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
NCT ID: NCT00011895
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2001-02-28
Brief Summary
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Detailed Description
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An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Abacavir sulfate, Lamivudine and Zidovudine
Efavirenz
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Locations
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Phoenix Body Positive
Phoenix, Arizona, United States
Health for Life Clinic
Little Rock, Arkansas, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, United States
Pacific Horizons Med Group
San Francisco, California, United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Infectious Disease Consultants
Altamonte Springs, Florida, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States
SBMA Research
Miami Beach, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, United States
Northstar Med Clinic
Chicago, Illinois, United States
University of Louisville / ID Division
Louisville, Kentucky, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, United States
Boston Med Ctr
Boston, Massachusetts, United States
Dr Paul Benson
Berkley, Michigan, United States
Hennepin County Med Ctr
Minneapolis, Minnesota, United States
Regions Hosp / HIV/AIDS Program
Saint Paul, Minnesota, United States
CRC of Mississippi
Jackson, Mississippi, United States
Wellness Ctr / Las Vegas
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
NJCRI
Newark, New Jersey, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States
ID Consultants
Charlotte, North Carolina, United States
East Carolina Univ School of Medicine
Greenville, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Univ of Oklahoma Infectious Disease Institute
Oklahoma City, Oklahoma, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, United States
Univ of Tennessee Med Ctr at Knoxville
Knoxville, Tennessee, United States
Texas Tech Health Sciences Ctr
El Paso, Texas, United States
AIDS Outreach Center
Fort Worth, Texas, United States
Metroplex Infectious Disease
Fort Worth, Texas, United States
Tarrant County Infectious Diseases Associates
Fort Worth, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
Diversified Med Practices, PA
Houston, Texas, United States
Infectious Diseases Associates of Houston
Houston, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Infectious Disease Consultants
Fairfax, Virginia, United States
Swedish Med Ctr
Seattle, Washington, United States
Countries
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Other Identifiers
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ESS40013
Identifier Type: -
Identifier Source: secondary_id
308B
Identifier Type: -
Identifier Source: org_study_id