Condition category
Infections and Infestations
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
10/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr R Blumer

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Endocrinology and Metabolism
F5-162
P.O. Box 22660
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 9111
r.blumer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Rosi-trial

Study hypothesis

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

Approval received from the Medical ethical committee of the Academical Medical Centre in Amsterdam on the 2nd October 2002 (ref: MEC 02/126).

Study design

Randomised, placebo controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 Specified

Drug names

Rosiglitazone

Primary outcome measures

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
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

1. Lipid levels
2. Glucoregulatory hormones
3. Adipocytokines
4. Liver enzymes
5. Waist-hip ratio

Overall trial start date

03/11/2003

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

15

Participant 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

Recruitment start date

03/11/2003

Recruitment end date

01/08/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Industry

Funder name

GlaxoSmithKline (The Netherlands)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes