Lipodystrophy in human immunodeficiency virus-infected patients: a randomised, open-label study with rosiglitazone and metformin

ISRCTN ISRCTN36766542
DOI https://doi.org/10.1186/ISRCTN36766542
Secondary identifying numbers 02/238
Submission date
28/04/2005
Registration date
10/06/2005
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 Eelco de Koning
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleLipodystrophy in human immunodeficiency virus-infected patients: a randomised, open-label study with rosiglitazone and metformin
Study objectivesRosiglitazone and metformin improve body fat distribution,
insulin sensitivity and cardiovascular risk indices in Human Immunodeficiency Virus (HIV)-infected patients with lipodystrophy.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHuman Immunodeficiency Virus (HIV)
InterventionRosiglitazone versus metformin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Rosiglitazone and metformin
Primary outcome measureThe area under the curve for insulin after the oral glucose tolerance test.
Secondary outcome measuresSubcutaneous and visceral abdominal fat by single-slice Computed Tomography (CT) scan, fasting lipid profile and ultrasound assessment of endothelial function (flow-mediated vasodilation).
Overall study start date01/03/2003
Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants39
Key inclusion criteriaHIV-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.
Key exclusion criteria1. 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
Date of first enrolment01/03/2003
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Department of Nephrology
Leiden
3584 CX
Netherlands

Sponsor information

GlaxoSmithKline (The Netherlands)
Industry

Huis ter Heideweg 62
Zeist
3705 LZ
Netherlands

ROR logo "ROR" https://ror.org/05atcw115

Funders

Funder type

Industry

GlaxoSmithKline
Government organisation / For-profit companies (industry)
Alternative name(s)
GlaxoSmithKline plc., GSK plc., GSK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 06/09/2005 Yes No

Editorial Notes

03/10/2017: internal review.