Condition category
Infections and Infestations
Date applied
28/04/2005
Date assigned
10/06/2005
Last edited
18/08/2006
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 Eelco de Koning

ORCID ID

Contact details

Department of Nephrology
Leiden University Medical Center Utrecht
Room C3-P
Leiden
3584 CX
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02/238

Study information

Scientific title

Acronym

Study hypothesis

Rosiglitazone and metformin improve body fat distribution,
insulin sensitivity and cardiovascular risk indices in Human Immunodeficiency Virus (HIV)-infected patients with lipodystrophy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Human Immunodeficiency Virus (HIV)

Intervention

Rosiglitazone versus metformin

Intervention type

Drug

Phase

Not Specified

Drug names

Rosiglitazone and metformin

Primary outcome measures

The area under the curve for insulin after the oral glucose tolerance test.

Secondary outcome measures

Subcutaneous and visceral abdominal fat by single-slice Computed Tomography (CT) scan, fasting lipid profile and ultrasound assessment of endothelial function (flow-mediated vasodilation).

Overall trial start date

01/03/2003

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

HIV-Ribonucleic Acid (RNA) values less than 10,000 copies/ml, the presence of lipodystrophy, and treatment with Highly Active Anti-Retroviral Therapy (HAART) for at least 18 months with no changes in the treatment regimen during six months prior to inclusion.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

39

Participant exclusion criteria

1. The presence of opportunistic infectious disease or malignancies, renal-, thyroid- and/or liver disease
2. Body Mass Index (BMI) more than 30 kg/m^2
3. Fasting plasma glucose more than 7 mmol/l
4. Triglycerides more than 10 mmol/l and/or total cholesterol more than 8 mmol/l
5. Alcohol intake more than three units (36 g) per day

Recruitment start date

01/03/2003

Recruitment end date

31/08/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Nephrology
Leiden
3584 CX
Netherlands

Sponsor information

Organisation

GlaxoSmithKline (The Netherlands)

Sponsor details

Huis ter Heideweg 62
Zeist
3705 LZ
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

GlaxoSmithKline

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16144892

Publication citations

  1. van Wijk JP, de Koning EJ, Cabezas MC, op't Roodt J, Joven J, Rabelink TJ, Hoepelman AI, Comparison of rosiglitazone and metformin for treating HIV lipodystrophy: a randomized trial., Ann. Intern. Med., 2005, 143, 5, 337-346.

Additional files

Editorial Notes