Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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
2 other identifiers
interventional
400
1 country
42
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 2, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2002
March 2, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
Phoenix Body Positive
Phoenix, Arizona, 85006, United States
Health for Life Clinic
Little Rock, Arkansas, 72205, United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
Infectious Disease Consultants
Altamonte Springs, Florida, 32701, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136, United States
SBMA Research
Miami Beach, Florida, 33140, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, 60612, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
University of Louisville / ID Division
Louisville, Kentucky, 40202, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Dr Paul Benson
Berkley, Michigan, 48072, United States
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415, United States
Regions Hosp / HIV/AIDS Program
Saint Paul, Minnesota, 55101, United States
CRC of Mississippi
Jackson, Mississippi, 39202, United States
Wellness Ctr / Las Vegas
Las Vegas, Nevada, 89102, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
NJCRI
Newark, New Jersey, 07103, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021, United States
ID Consultants
Charlotte, North Carolina, 28203, United States
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858, United States
Summa Health System
Akron, Ohio, 44304, United States
Univ of Oklahoma Infectious Disease Institute
Oklahoma City, Oklahoma, 73117, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Univ of Tennessee Med Ctr at Knoxville
Knoxville, Tennessee, 37920, United States
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905, United States
AIDS Outreach Center
Fort Worth, Texas, 76104, United States
Metroplex Infectious Disease
Fort Worth, Texas, 76104, United States
Tarrant County Infectious Diseases Associates
Fort Worth, Texas, 76104, United States
Therapeutic Concepts
Houston, Texas, 77004, United States
Diversified Med Practices, PA
Houston, Texas, 77027, United States
Infectious Diseases Associates of Houston
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22003, United States
Infectious Disease Consultants
Fairfax, Virginia, 22030, United States
Swedish Med Ctr
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 2, 2001
First Posted
August 31, 2001
Study Start
February 1, 2001
Last Updated
June 24, 2005
Record last verified: 2002-03