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

Sponsor:	GlaxoSmithKline
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00011895

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Efavirenz	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Abacavir Efavirenz Abacavir sulfate Trizivir

U.S. FDA Resources

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

Estimated Enrollment:	400
Study Start Date:	February 2001

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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011895

Hide Study Locations

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	308B, ESS40013
Study First Received:	March 2, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00011895 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
Zidovudine
Lamivudine
Drug Combinations
RNA, Viral

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
efavirenz

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009