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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00005764 |
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 |
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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.
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:
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 Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Metabolic Diseases Skin Diseases Zalcitabine Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Antiviral Agents Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents HIV Seropositivity HIV Infections Lipodystrophy Sexually Transmitted Diseases Abacavir Retroviridae Infections Metabolic Disorder Lipid Metabolism Disorders |
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 |