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NCT00011895 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00011895
Other study ID # 308B
Secondary ID ESS40013
Status Active, not recruiting
Phase Phase 4
First received March 2, 2001
Last updated June 23, 2005
Start date February 2001

Study information
Verified date March 2002
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Abacavir sulfate, Lamivudine and Zidovudine

• Efavirenz

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

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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