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

• Register: EUCTR
• Last refreshed on: 18 April 2016
• Main ID: EUCTR2015-004427-31-SE
• Date of registration: 14/01/2016
• Prospective Registration: Yes
• Primary sponsor: Gothenburg University
• Public title: Could the new HIV-drug "TAF" reduce inflammation inside the central nervous system?
• Scientific title: Tenofovir Alafenamide Fumarate (TAF) effect on residual intrathecal immune activation
• Date of first enrolment: 07/03/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004427-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Contacts

• Name: Magnus Gisslén
• Affiliation: Gothenburg University

• Name: Magnus Gisslén
• Affiliation: Gothenburg University

Key inclusion & exclusion 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 < 50 copies/mL for more than 12 months.
3. No neurological symptoms or severe neurocognitive impairment.
4. No pre-treatment central nervous system opportunistic infection/tumour or HIV-associated dementia.
5. Lumbar puncture performed in the longitudinal cerebrospinal fluid study (University of Gothenburg) between 6 and 18 months before study entry.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Not on successful antiretroviral therapy.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

HIV-infection in the central nervous system

Intervention(s)

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

Primary Outcome(s)

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.

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 Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable.

Secondary end point(s): Not applicable.

Secondary ID(s)

TAFCNS2015

Source(s) of Monetary Support

Gilead