Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) - Full Text View

Sponsor:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00004981

Purpose

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.

Condition	Intervention	Phase
HIV Infections	Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Abacavir Combivir Abacavir sulfate

U.S. FDA Resources

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

Estimated Enrollment:

230

Detailed Description:

Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.

Eligibility

Ages Eligible for Study:	18 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 18 years old.
Are HIV-positive.
Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
Have CD4+ cell count greater than 200 cells/mm3.
Agree to use effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have been diagnosed with AIDS.
Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
Have hepatitis.
Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
Are allergic to any of the study drugs.
Abuse alcohol or drugs.
Will not be available for the entire 24-week study period.
Are pregnant or breast-feeding.
Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
Are enrolled in another experimental drug study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004981

Locations

United States, California
St Lukes Medical Group
San Diego, California, United States, 92101
Robert Scott MD
Oakland, California, United States, 94609
AIDS Healthcare Foundation
Los Angeles, California, United States, 900276069
Tower Infectious Disease Med Ctr
Los Angeles, California, United States, 90048
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, United States, 33142
Saint Josephs Comprehensive Research Institute
Tampa, Florida, United States, 33607
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, Missouri
Research Med Ctr
Kansas City, Missouri, United States, 64111
United States, New York
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
St Luke Roosevelt Hosp
New York, New York, United States, 10011
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
United States, Pennsylvania
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
Lehigh Valley Hosp
Allentown, Pennsylvania, United States, 18105
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States, 191021192
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
United States, Tennessee
Univ of Tennessee
Memphis, Tennessee, United States, 38163
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, United States, 37203
United States, Texas
Univ of Texas Med Branch
Galveston, Texas, United States, 77555
Therapeutic Concepts
Houston, Texas, United States, 77004
Nicholas Bellos
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

Study ID Numbers:	308A, ESS40005
Study First Received:	March 13, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004981 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Lamivudine
RNA, Viral

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Combivir
abacavir

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Dideoxynucleosides
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir

Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
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 February 08, 2010