Maraviroc Abacavir STudy - effect on Endothelial Recovery

Phase 4

Completed

• Conditions: hart- en vaatziekten; HIV; 10047438

• Registration Number: NL-OMON38245
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks<br /><br>of treatment with maraviroc (primary endpoint)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Change in endothelial function measured by EndoPAT<br /><br>-Change in markers of chronic inflammation<br /><br>-Change in markers of immune activation<br /><br>-change in markers of endothelial function<br /><br>-Changes in plasma HIV-RNA below 50 copies/ml </p><br>