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Could the new HIV-drug "TAF" reduce inflammation inside the central nervous system?

Tenofovir Alafenamide Fumarate (TAF) effect on residual intrathecal immune activation

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-004427-31-SE
Enrollment
Unknown
Registered
2016-01-14
Start date
2016-03-07
Completion date
Unknown
Last updated
2016-04-18

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

Conditions

HIV-infection in the central nervous system

Interventions

Product Name: tenofovir alafenamide fumarate (TAF) Pharmaceutical Form: Tablet

Sponsors

Gothenburg University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Stable antiretroviral therapy with TDF/FTC or ABC/3TC + 3rd agent (PI/r, NNRTI, or INI) for more than18 months. 2. Plasma HIV-RNA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Not on successful antiretroviral therapy.

Design outcomes

Primary

MeasureTime frame
Main Objective: Our main objective is to find out if there is any effect on cerebrospinal fluid HIV-RNA levels or levels of intrathecal immune activation after switching from either ABC/3TC or TDF/FTC to TAF/FTC.;Secondary Objective: Not applicable;Primary end point(s): Change in cerebrospinal fluid viral load or intrathecal immune activation.;Timepoint(s) of evaluation of this end point: 12 months after inclusion in the study.—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.—

Countries

Sweden

Contacts

Public ContactMagnus Gisslén

Gothenburg University

magnus.gisslen@gu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026