Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02/238
Study information
Scientific title
Lipodystrophy in human immunodeficiency virus-infected patients: a randomised, open-label study with rosiglitazone and metformin
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 Applicable
Drug names
Rosiglitazone and metformin
Primary outcome measure
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 (if study stopped)
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
Leiden University Medical Center
Department of Nephrology
Leiden
3584 CX
Netherlands
Funders
Funder type
Industry
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list
2005 results in https://www.ncbi.nlm.nih.gov/pubmed/16144892
Publication citations
-
Results
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.