StatHIV trial.
- Conditions
- HIV infectionImmune activation
- Registration Number
- NL-OMON23117
- Lead Sponsor
- Stichting Research Interne Geneeskunde, OLVG, Amsterdam, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Adults 18 years of age or older;
2. HIV-1 infection, as documented by a licensed ELISA test kit and confirmed by a Western blot assay;
Exclusion Criteria
1. Pregnancy or breast feeding;
2. Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patient's ability to participate in the study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: To investigate the effect of rosuvastatin 20 mg qd on subsequent immune activation markers in treatment-naïve HIV-patients:<br /><br>Circulating LPS (LAL assay), TLR mRNA expression in whole blood, circulating IL-6, D-dimer, hsCRP, CD38 and HLA-DR expression on lymphocytes, and microparticles and endogenous thrombin potential as indicators of endothelial damage.
- Secondary Outcome Measures
Name Time Method Secondary Objective: To investigate the effect of rosuvastatin 20 mg qd on HIV viral load, CD4 cell count, total cholesterol and cholesterol subfractions, ApoB/ApoA1 ratio, CK, liver enzymes, renal function, and complete blood count as well as on markers of quality of life measured with the EuroQol-6D questionnaire in treatment-naïve HIV-patients throughout the study period.