Can the use of the Peroxisome Proliferator-Activated Receptor (PPAR)-gamma agonist rosiglitazone reverse the abnormal distribution of fat, as well as disturbances in glucose and lipid metabolism in Human Immunodeficiency Virus (HIV)-associated lipodystrophy syndrome?
Not Applicable
Completed
- Conditions
- Human Immunodeficiency Virus (HIV)-associated lipodystrophy syndromeInfections and InfestationsHuman Immunodeficiency Virus
- Registration Number
- ISRCTN78808170
- Lead Sponsor
- Academic Medical Centre (AMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
1. Male
2. Aged more than 18 years
3. Documented HIV-1 infection
4. HIV-Ribonucleic Acid (RNA) less than 50 copies/ml
5. Clinical evidence of lipodystrophy
6. More than 36 weeks no use of a protease inhibitor
7. More than 24 weeks no use of d4T
8. More than 12 weeks on a stabile regimen
Exclusion Criteria
1. Active hepatitis
2. Alanine aminotransferase (ALAT)/Aspartate aminotransferase (ASAT) more than 2.5 x above normal level
3. Total bilirubin 2.5 x above normal level
4. Lactate 2.5 x above normal level
5. Anaemia
6. Use of medication influencing metabolism/blood clotting
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Insulin sensitivity at the level of glucose production by liver, glucose uptake by muscle and fat and lipolysis. This will be measured by a hyperinsulinaemic clamp using stabile isotopes (d2-glucose and D5-glycerol) and by performing muscle biopsies at baseline and after four months<br>2. Fat distribution by a Dual Energy X-ray Absorptiometry (DEXA)- and a Computed Tomography (CT)-scan at baseline and after four months
- Secondary Outcome Measures
Name Time Method 1. Lipid levels<br>2. Glucoregulatory hormones<br>3. Adipocytokines<br>4. Liver enzymes<br>5. Waist-hip ratio