A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients
- Conditions
- HIV InfectionsLipodystrophy
- Registration Number
- NCT00005764
- Lead Sponsor
- Glaxo Wellcome
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
THE Clinic
🇺🇸Los Angeles, California, United States
Tower Infectious Disease Med Ctr
🇺🇸Los Angeles, California, United States
St Lukes Medical Group
🇺🇸San Diego, California, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
North Broward Hosp District / HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Duval County Health Department
🇺🇸Jacksonville, Florida, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
Jersey Shore Med Ctr
🇺🇸Neptune, New Jersey, United States
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