Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs - Article Sustiva
Clinical Trial: Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) with Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
This study is no longer recruiting patients.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Abacavir sulfate, Lamivudine and Zidovudine |
|Phase IV |
MedlinePlus related topics: AIDS
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
Expected Total Enrollment: 400
Study start: February 2001
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.
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
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.
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.
Phoenix Body Positive, Phoenix, Arizona, 85006, United States
Health for Life Clinic, Little Rock, Arkansas, 72205, United States
Pacific Horizons Med Group, San Francisco, California, 94115, United States
Orange County Ctr for Special Immunology, Fountain Valley, California, 92708, United States
Beacon Clinic / Boulder Community Hosp, Boulder, Colorado, 80304, United States
District of Columbia
Georgetown Univ Med Ctr, Washington, District of Columbia, 20007, United States
Dupont Circle Physicians Group, Washington, District of Columbia, 200091104, United States
Infectious Disease Consultants, Altamonte Springs, Florida, 32701, United States
Univ of Miami / Jackson Memorial Hosp, Miami, Florida, 33136, United States
North Broward Hosp District / HIV Clinical Research, Fort Lauderdale, Florida, 33311, 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, St. Paul, Minnesota, 55101, United States
CRC of Mississippi, Jackson, Mississippi, 39202, United States
Wellness Ctr / Las Vegas, Las Vegas, Nevada, 89102, United States
NJCRI, Newark, New Jersey, 07103, United States
Hackensack University Medical Center, Hackensack, New Jersey, 07601, 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
East Carolina Univ School of Medicine, Greenville, North Carolina, 27858, United States
ID Consultants, Charlotte, North Carolina, 28203, United States
Summa Health System, Akron, Ohio, 44304, United States
Associates in Med and Mental Health, Tulsa, Oklahoma, 74114, United States
Univ of Oklahoma Infectious Disease Institute, Oklahoma City, Oklahoma, 73117, 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
Infectious Diseases Associates of Houston, Houston, Texas, 77030, United States
Diversified Med Practices, PA, Houston, Texas, 77027, United States
Therapeutic Concepts, Houston, Texas, 77004, United States
AIDS Outreach Center, Fort Worth, Texas, 76104, United States
Tarrant County Infectious Diseases Associates, Fort Worth, Texas, 76104, United States
Metroplex Infectious Disease, Fort Worth, Texas, 76104, 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
Record last reviewed: March 2002
Last Updated: October 13, 2004
Record first received: March 2, 2001
ClinicalTrials.gov Identifier: NCT00011895
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005