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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36766542

Enrollment

Registered

2005-06-10

Start date

2003-03-01

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus (HIV) Infections and Infestations Human Immunodeficiency Virus (HIV)

Interventions

Rosiglitazone versus metformin

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The area under the curve for insulin after the oral glucose tolerance test.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026