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
Protocol serial number	02/238
Sponsor	GlaxoSmithKline (The Netherlands)
Funder	GlaxoSmithKline

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Eelco de Koning
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Lipodystrophy in human immunodeficiency virus-infected patients: a randomised, open-label study with rosiglitazone and metformin
Study objectives	Rosiglitazone 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) studied	Human Immunodeficiency Virus (HIV)
Intervention	Rosiglitazone versus metformin
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Rosiglitazone and metformin
Primary outcome measure(s)	The area under the curve for insulin after the oral glucose tolerance test.
Key secondary outcome measure(s)	Subcutaneous and visceral abdominal fat by single-slice Computed Tomography (CT) scan, fasting lipid profile and ultrasound assessment of endothelial function (flow-mediated vasodilation).
Completion date	31/08/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	39
Key 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.
Key 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
Date of first enrolment	01/03/2003
Date of final enrolment	31/08/2004

Leiden University Medical Center

Department of Nephrology
Leiden
3584 CX
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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

03/10/2017: internal review.