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

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 - LOWERIT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44785

Enrollment

Registered

2014-06-04

Start date

2014-11-19

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aids HIV

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Evolution, as measured by genetic variation of viral clones at different time points. This outcome gives an indication if the low-level viremia is based on viral replication or production.	—

Secondary

Measure	Time frame
HIV-RNA-level, Immunological markers, neurocognitive performance, periodontal inflammation, HIV resistance associated mutations, Genetic compartmentalization of HIV (CSF-plasma and saliva-plasma comparison).	—

Countries

Netherlands

Outcome results