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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00004981 |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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 |
Study ID Numbers: | 308A, ESS40005 |
Study First Received: | March 13, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004981 |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Zidovudine Drug Administration Schedule Lamivudine RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Combivir abacavir |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lamivudine |
Zidovudine Dideoxynucleosides Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |