hart- en vaatziekten HIV
Conditions
Interventions
Randomisation into two arms: A and B. In arm A maraviroc will be added to the
abacavir-containing regimen, while study subjects in arm B will continue their
abacavir-containing regimen. After 8 week
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Age > 18 years -HIV-1 infection -Treatment with antiretroviral regimen containing abacavir for at least the previous 3 months -Undetectable plasma HIV RNA (50 cp/ml) for at least 6 months (one *blip* allowed, which is defined as a detectable plasma HIV-RNA level between 50 and 400 copies/ml, preceded and followed by undetectable ( 200 cells/µL -Signed informed consent
Exclusion criteria
Exclusion criteria: -Pregnancy -Breastfeeding -Allergy for peanuts or soya -Hypersensitivity for maraviroc -Treatment of underlying malignancy -Acute infection in the preceding 30 days -Renal insufficiency requiring hemodialysis -Acute or decompensated chronic hepatitis -Modification of antiretroviral regimen in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of treatment with maraviroc (primary endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in endothelial function measured by EndoPAT -Change in markers of chronic inflammation -Change in markers of immune activation -change in markers of endothelial function -Changes in plasma HIV-RNA below 50 copies/ml | — |
Countries
Netherlands
Outcome results
None listed