Tenofovir Alafenamide Fumarate (TAF) Effect on Residual Intrathecal Immune Activation

• Status: Completed
• Trial end date: 2018-07-15
• Target enrollment: 0
• Participant gender: All

Summary

Many HIV-infected individuals on effective antiretroviral therapy with suppressed HIV RNA levels in blood as well as in cerebrospinal fluid have signs of low-level intrathecal inflammation. Our aim is to study if changing the nucleoside backbone in an antiretroviral regimen can decrease the residual intrathecal immune activation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Stable ART with TDF/FTC or ABC/3TC + 3rd agent (PI/r, NNRTI, or INI) >18 months

• Plasma HIV RNA < 50 copies/mL >12 months

• Lumbar puncture performed in the longitudinal CSF study (University of Gothenburg) between 6 and 18 months before study entry

Exclusion Criteria:

• Neurological symptoms or severe neurocognitive impairment

• Pre-treatment CNS opportunistic infection/ tumour or HIV-associated dementia

• Pregnancy