Investigation of the effects of switching to a high genetic barrier protease inhibitor based regimen on low level viremia, immune activation and neurocognitive performance in patients on antiviral therapy
Completed
- Conditions
- aidsHIV1002146010047438
- Registration Number
- NL-OMON44785
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Inclusion Criteria
a. Using cART for at least 48 weeks, including 2 NRTIs + 1 NNRTI or 1 PI or 1INSTI
b. Low level viremia (2 or more HIV viral loads between 50-1000 cp/mL in a year, without Target Not Detected (TND) in between)
c. Viral load <200cp/mL at at least one measurement since starting cART
d. A planned therapy change of the PI or NNRTI to DRV/r
Exclusion Criteria
a. Presence of known pol major IAS mutations for darunavir (I47V; I50V; I54M/L; L76V; I84V)
b. Signs of opportunistic infections
c. Major suspicion of inadequate therapy adherence
d. Severe depression at screening (BDI score >30)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evolution, as measured by genetic variation of viral clones at different time<br /><br>points. This outcome gives an indication if the low-level viremia is based on<br /><br>viral replication or production. </p><br>
- Secondary Outcome Measures
Name Time Method <p>HIV-RNA-level, Immunological markers, neurocognitive performance, periodontal<br /><br>inflammation, HIV resistance associated mutations, Genetic compartmentalization<br /><br>of HIV (CSF-plasma and saliva-plasma comparison).</p><br>