Can the use of the PPAR-gamma agonist rosiglitazon reverse the abnormal distribution of fat, as well as disturbances in glucose and lipid metabolism in HIV-associated lipodystrophy syndrome?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25981

Enrollment

Registered

2005-11-04

Start date

2003-11-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV+ patients, with lipodystrophy (based on fat distribution disturbances), not using d4T nor a protease inhibitor.

Interventions

Patients will receive either Rosiglitazon 8 mg daily (2/3) or placebo (1/3) during 4 months.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male; 2. age>18 years; 3. documented HIV-1 infection; 4. HIV-RNA36 weeks no use of a protease inhibitor; 7. > 24 no use of d4T, >12 weeks on a stabile regimen.

Exclusion criteria

Exclusion criteria: 1. Active hepatitis; 2. ALAT/ASAT>2.5x above normal level; 3. total bilirubin 2.5x above normal level; 4. lactate 2.5x above normal level; 5. anemia; 6. use of medication influencing metabolism/ blood clotting.

Design outcomes

Primary

Measure	Time frame
1. Insulin sensitivity at the level of glucose production by liver, glucose uptake by muscle+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 4 months; 2. Fat distribution by a DEXA- and a CT-scan at baseline and after 4 months.	—

Secondary

Measure	Time frame
1. Lipid levels; 2. Glucoregulatory hormones; 3. Adipocytokines; 4. Liver enzymes; 5. Waist-hip ratio.	—

Contacts

Public ContactR. Blumer

Academic medical Center (AMC), Department of Endocrinology and Metabolism, F5-162, P.O. Box 22660

r.blumer@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)