Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
NCT ID: NCT00004981
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
230 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Abacavir sulfate, Lamivudine and Zidovudine
Lamivudine/Zidovudine
Abacavir sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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AIDS Healthcare Foundation
Los Angeles, California, United States
Tower Infectious Disease Med Ctr
Los Angeles, California, United States
Robert Scott MD
Oakland, California, United States
St Lukes Medical Group
San Diego, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, United States
Saint Josephs Comprehensive Research Institute
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
New England Med Ctr
Boston, Massachusetts, United States
Research Med Ctr
Kansas City, Missouri, United States
Addiction Research and Treatment Corp
Brooklyn, New York, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
St Luke Roosevelt Hosp
New York, New York, United States
Lehigh Valley Hosp
Allentown, Pennsylvania, United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States
Burnside Clinic
Columbia, South Carolina, United States
Univ of Tennessee
Memphis, Tennessee, United States
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, United States
Nicholas Bellos
Dallas, Texas, United States
Univ of Texas Med Branch
Galveston, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
Countries
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Other Identifiers
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ESS40005
Identifier Type: -
Identifier Source: secondary_id
308A
Identifier Type: -
Identifier Source: org_study_id