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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate, Lamivudine and Zidovudine
Efavirenz
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Zidovudine, Lamivudine, Drug Combinations, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Body Positive
  • Health for Life Clinic
  • Orange County Ctr for Special Immunology
  • Pacific Horizons Med Group
  • Beacon Clinic / Boulder Community Hosp
  • Georgetown Univ Med Ctr
  • Dupont Circle Physicians Group
  • Infectious Disease Consultants
  • North Broward Hosp District / HIV Clinical Research
  • SBMA Research
  • Univ of Miami / Jackson Memorial Hosp
  • Infectious Disease Specialists of Atlanta
  • Cook County Gen Hosp / Division of Infect Diseases
  • Northstar Med Clinic
  • University of Louisville / ID Division
  • HIV Outpatient Clinics / LA State Univ Med Ctr
  • Boston Med Ctr
  • Dr Paul Benson
  • Hennepin County Med Ctr
  • Regions Hosp / HIV/AIDS Program
  • CRC of Mississippi
  • Wellness Ctr / Las Vegas
  • Hackensack University Medical Center
  • NJCRI
  • SUNY / Health Sciences Ctr at Brooklyn
  • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
  • ID Consultants
  • East Carolina Univ School of Medicine
  • Summa Health System
  • Univ of Oklahoma Infectious Disease Institute
  • Associates in Med and Mental Health
  • Univ of Tennessee Med Ctr at Knoxville
  • Texas Tech Health Sciences Ctr
  • AIDS Outreach Center
  • Metroplex Infectious Disease
  • Tarrant County Infectious Diseases Associates
  • Therapeutic Concepts
  • Diversified Med Practices, PA
  • Infectious Diseases Associates of Houston
  • Infectious Disease Physicians Inc
  • Infectious Disease Consultants
  • Swedish Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 2, 2001
Last Updated
June 23, 2005
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00011895
Brief Title
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

2. Study Status

Record Verification Date
March 2002
Overall Recruitment Status
Unknown status
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, Lamivudine, Drug Combinations, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate, Lamivudine and Zidovudine
Intervention Type
Drug
Intervention Name(s)
Efavirenz

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Health for Life Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Orange County Ctr for Special Immunology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Beacon Clinic / Boulder Community Hosp
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
Infectious Disease Consultants
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
North Broward Hosp District / HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
SBMA Research
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Univ of Miami / Jackson Memorial Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Cook County Gen Hosp / Division of Infect Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
University of Louisville / ID Division
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
HIV Outpatient Clinics / LA State Univ Med Ctr
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Boston Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Dr Paul Benson
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Hennepin County Med Ctr
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Regions Hosp / HIV/AIDS Program
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
CRC of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Wellness Ctr / Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NJCRI
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
ID Consultants
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
East Carolina Univ School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Univ of Oklahoma Infectious Disease Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Univ of Tennessee Med Ctr at Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Texas Tech Health Sciences Ctr
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
AIDS Outreach Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Metroplex Infectious Disease
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Tarrant County Infectious Diseases Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Therapeutic Concepts
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Diversified Med Practices, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Infectious Diseases Associates of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Infectious Disease Consultants
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Swedish Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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