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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005764 |
Purpose
The purpose of this study is to see if the findings of increased lactic acid and abnormal fat distribution get better when d4T is replaced with abacavir, abacavir plus lamivudine, or Combivir (a pill containing lamivudine plus zidovudine) in HIV-positive patients taking anti-HIV therapy including stavudine (d4T).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Lipodystrophy |
Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Lamivudine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL) |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2000 |
Patients are allocated as follows: a) zidovudine-naive patients switch Combivir for d4t and b) zidovudine-experienced or -intolerant patients switch abacavir for d4t. Providers may choose between Combivir or abacavir as a switch for d4t when screening lactate levels are 2.2 mmol/L or more. Additionally, providers may choose to switch a maximum of 2 drugs, one of which must be d4t, in the regimen. Each patient receives 48 weeks of therapy. Visits are made at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Tests, including biopsies, are performed to measure changes in body fat distribution and changes in lactate levels. Virologic and immunologic outcomes, changes in physical signs of lipodystrophy, changes in self-reports of health-related quality-of-life survey and the Body Image Questionnaire, changes in lipid profile and other markers of metabolism, and safety parameters are evaluated also.
Eligibility| 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:
Contacts and Locations
Hide Study Locations| United States, California | |
| St Lukes Medical Group | |
| San Diego, California, United States, 92101 | |
| UCSD Treatment Ctr | |
| San Diego, California, United States, 921036329 | |
| Tower Infectious Disease Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| THE Clinic | |
| Los Angeles, California, United States, 90008 | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group | |
| Washington, District of Columbia, United States, 200091104 | |
| United States, Florida | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| Duval County Health Department | |
| Jacksonville, Florida, United States, 32206 | |
| North Broward Hosp District / HIV Clinical Research | |
| Fort Lauderdale, Florida, United States, 33311 | |
| United States, Illinois | |
| Northstar Med Clinic | |
| Chicago, Illinois, United States, 60657 | |
| United States, New Jersey | |
| Jersey Shore Med Ctr | |
| Neptune, New Jersey, United States, 07753 | |
| Infectious Disease Specialists of NJ | |
| Union, New Jersey, United States, 07083 | |
| South Jersey Infectious Diseases Inc | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, New York | |
| Bronx Veterans Affairs Med Ctr | |
| Bronx, New York, United States, 10468 | |
| Howard Grossman | |
| New York, New York, United States, 10011 | |
| Mt Vernon Hospital | |
| Mt. Vernon, New York, United States, 10550 | |
| Long Island College Hospital | |
| Brooklyn, New York, United States, 11217 | |
| Liberty Medical / Cabrini Hospital / Dept of Infec Diseases | |
| New York, New York, United States, 10003 | |
| Dr Lawrence Fontana | |
| New York, New York, United States, 10003 | |
| Boriken Neighborhood Health Center | |
| New York, New York, United States, 10035 | |
| Infectious Diseases Assoc of Brooklyn | |
| Brooklyn, New York, United States, 11215 | |
| United States, North Carolina | |
| Univ of North Carolina / SOCA | |
| Chapel Hill, North Carolina, United States, 275997030 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Summa Health System | |
| Akron, Ohio, United States, 44304 | |
| United States, Pennsylvania | |
| Philadelphia Veterans Administration Med Ctr | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15221 | |
| United States, Texas | |
| Gathe, Joseph, M.D. | |
| Houston, Texas, United States, 77004 | |
| Univ of Texas / Med School at Houston | |
| Houston, Texas, United States, 77030 | |
| Diversified Med Practices, PA | |
| Houston, Texas, United States, 77027 | |
| Central Texas Clinical Research | |
| Austin, Texas, United States, 78705 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
| United States, Washington | |
| Swedish Med Ctr | |
| Seattle, Washington, United States, 98122 | |
More Information
| Study ID Numbers: | 238T, ESS40010 |
| Study First Received: | May 30, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005764 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Zalcitabine Didanosine Drug Therapy, Combination Zidovudine Stavudine Lamivudine |
Blood Reverse Transcriptase Inhibitors Anti-HIV Agents Lipodystrophy Combivir Lactic Acid abacavir |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lipodystrophy Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Metabolic Diseases Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Skin Diseases, Metabolic Sexually Transmitted Diseases Lentivirus Infections |