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)
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Texas / Med School at Houston
🇺🇸Houston, Texas, United States
St Lukes Medical Group
🇺🇸San Diego, California, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Northstar Med Clinic
🇺🇸Chicago, Illinois, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
🇺🇸New York, New York, United States
Bronx Veterans Affairs Med Ctr
🇺🇸Bronx, New York, United States
Mt Vernon Hospital
🇺🇸Mt. Vernon, New York, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Gathe, Joseph, M.D.
🇺🇸Houston, Texas, United States
Duval County Health Department
🇺🇸Jacksonville, Florida, United States
Univ of North Carolina / SOCA
🇺🇸Chapel Hill, North Carolina, United States
Tower Infectious Disease Med Ctr
🇺🇸Los Angeles, California, United States
Infectious Diseases Assoc of Brooklyn
🇺🇸Brooklyn, New York, United States
THE Clinic
🇺🇸Los Angeles, California, United States
Philadelphia Veterans Administration Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Diversified Med Practices, PA
🇺🇸Houston, Texas, United States
Swedish Med Ctr
🇺🇸Seattle, Washington, United States
Boriken Neighborhood Health Center
🇺🇸New York, New York, United States
Jersey Shore Med Ctr
🇺🇸Neptune, New Jersey, United States
North Broward Hosp District / HIV Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Dr Lawrence Fontana
🇺🇸New York, New York, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Howard Grossman
🇺🇸New York, New York, United States
Long Island College Hospital
🇺🇸Brooklyn, New York, United States
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
South Jersey Infectious Diseases Inc
🇺🇸Somers Point, New Jersey, United States
Infectious Disease Specialists of NJ
🇺🇸Union, New Jersey, United States