A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)
Sponsor: Glaxo Wellcome
A PHASE4 clinical study on HIV Infections and Lipodystrophy, this trial is completed. The trial is conducted by Glaxo Wellcome and has accumulated 6 data snapshots since 2000. Infectious disease trials contribute critical data for public health response and treatment development.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE4
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE4
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE4
First recorded
May 2000
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Glaxo Wellcome
For direct contact, visit the study record on ClinicalTrials.gov .