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?
| ISRCTN | ISRCTN78808170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78808170 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funders | GlaxoSmithKline (The Netherlands), Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 03/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Blumer
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Endocrinology and Metabolism, F5-162
P.O. Box 22660
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| r.blumer@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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? A randomised controlled trial |
| Study acronym | Rosi-trial |
| Study objectives | Rosiglitazone results in an improvement in insulin sensitivity at the level of the liver as well as peripherally. In addition disturbances in fat distribution could improve, especially in this specific group of patients, who do not use d4T nor a protease inhibitor, which are known to cause lipodystrophy. |
| Ethics approval(s) | Approval received from the Medical ethical committee of the Academical Medical Centre in Amsterdam on the 2nd October 2002 (ref: MEC 02/126). |
| Health condition(s) or problem(s) studied | Human Immunodeficiency Virus (HIV)-associated lipodystrophy syndrome |
| Intervention | Patients will receive either rosiglitazone 8 mg daily (2/3) or placebo (1/3) during four months. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rosiglitazone |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Lipid levels |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/11/2003 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No |
Editorial Notes
03/10/2017: Publication reference added.
