NCT00005764

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• HIV Infections
• Lipodystrophy

Interventions

Type	Name	Description
DRUG	Lamivudine/Zidovudine
DRUG	Abacavir sulfate
DRUG	Lamivudine

Timeline

• Start date: 2000-05-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

31 sites across 1 country: United States