Maraviroc Abacavir STudy – effect on Endothelial Recovery - MASTER

Conditions: -Human Imunodeficiency Virus (HIV) infection-Endothelial dysfunction in HIV-infected patients-immune activation in HIV-infected patients-cardiovascular complications in HIV-infecetd patients
MedDRA version: 12.1Level: LLTClassification code 10008919Term: Chronic HIV infection
MedDRA version: 12.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecified
MedDRA version: 12.1Level: LLTClassification code 10008922Term: Chronic infection with HIV
MedDRA version: 12.1Level: LLTClassification code 10048554Term: Endothelial dysfunction

Registration Number: EUCTR2010-022641-25-NL

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

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 (<50 copies/ml) plasma HIV-RNA measurements)
-CD4+ cell count > 200 cells/µL
-Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect addition of maraviroc to an abacavir-containing regimen on endothelial function.;Secondary Objective: To assess the effect of addition of maraviroc to an abacavir-containing regimen on parameters of chronic inflammation and immune activation. ;Primary end point(s): Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of maraviroc treatment

Secondary Outcome Measures