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
Scientific
Leiden University Medical Center
Department of Nephrology
Room C3-P
Leiden
3584 CX
Netherlands
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2003 |
Completion date | 31/08/2004 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Department of Nephrology
Leiden
3584 CX
Netherlands
Leiden
3584 CX
Netherlands
Sponsor information
GlaxoSmithKline (The Netherlands)
Industry
Industry
Huis ter Heideweg 62
Zeist
3705 LZ
Netherlands
https://ror.org/05atcw115 |
Funders
Funder type
Industry
GlaxoSmithKline
Government organisation / For-profit companies (industry)
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.