A prospective open-label study to investigate the effects of switching to a darunavir based regimen on low level viremia, immune activation and neurocognitive performance in patients on antiviral therapy.
Phase 4
Withdrawn
- Conditions
- aidsHIV1002146010047438
- Registration Number
- NL-OMON38997
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 65
Inclusion Criteria
a. Using cART for at least 48 weeks, including 2 NRTIs + 1 NNRTI or 1 PI
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 <200 cp/mL at at least one measurement since starting cART.
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)
e. Severe hepatic impairment (Child-Pugh Class C)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of subjects with virological response during intervention will<br /><br>be compared to baseline and categorized according to responders (viral load <50<br /><br>c/mL at 24 weeks) and non responders (viral load >50 cp/mL at 24 weeks). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Immunological markers, neurocognitive performance, periodontal inflammation,<br /><br>HIV resistance associated mutations, HIV genetic variation (RNA and proviral<br /><br>DNA). Genetic compartmentalization of HIV (CSF-plasma and saliva-plasma<br /><br>comparison). </p><br>