Clinical trial NCT00011895: Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Zidovudine
Lamivudine
Drug Combinations
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Little Rock
country: United States
facility: Health for Life Clinic
state: Arkansas
city: Fountain Valley
country: United States
facility: Orange County Ctr for Special Immunology
state: California
city: San Francisco
country: United States
facility: Pacific Horizons Med Group
state: California
city: Boulder
country: United States
facility: Beacon Clinic / Boulder Community Hosp
state: Colorado
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Infectious Disease Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District / HIV Clinical Research
state: Florida
city: Miami Beach
country: United States
facility: SBMA Research
state: Florida
city: Miami
country: United States
facility: Univ of Miami / Jackson Memorial Hosp
state: Florida
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Cook County Gen Hosp / Division of Infect Diseases
state: Illinois
city: Chicago
country: United States
facility: Northstar Med Clinic
state: Illinois
city: Louisville
country: United States
facility: University of Louisville / ID Division
state: Kentucky
city: New Orleans
country: United States
facility: HIV Outpatient Clinics / LA State Univ Med Ctr
state: Louisiana
city: Boston
country: United States
facility: Boston Med Ctr
state: Massachusetts
city: Berkley
country: United States
facility: Dr Paul Benson
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Med Ctr
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hosp / HIV/AIDS Program
state: Minnesota
city: Jackson
country: United States
facility: CRC of Mississippi
state: Mississippi
city: Las Vegas
country: United States
facility: Wellness Ctr / Las Vegas
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Newark
country: United States
facility: NJCRI
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY / Health Sciences Ctr at Brooklyn
state: New York
city: New York
country: United States
facility: Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
state: New York
city: Charlotte
country: United States
facility: ID Consultants
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Univ School of Medicine
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Oklahoma City
country: United States
facility: Univ of Oklahoma Infectious Disease Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Associates in Med and Mental Health
state: Oklahoma
city: Knoxville
country: United States
facility: Univ of Tennessee Med Ctr at Knoxville
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech Health Sciences Ctr
state: Texas
city: Fort Worth
country: United States
facility: AIDS Outreach Center
state: Texas
city: Fort Worth
country: United States
facility: Metroplex Infectious Disease
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County Infectious Diseases Associates
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts
state: Texas
city: Houston
country: United States
facility: Diversified Med Practices, PA
state: Texas
city: Houston
country: United States
facility: Infectious Diseases Associates of Houston
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Fairfax
country: United States
facility: Infectious Disease Consultants
state: Virginia
city: Seattle
country: United States
facility: Swedish Med Ctr
state: Washington
Study officials:
References: