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

• Conditions: HIV-infection in the central nervous system; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-004427-31-SE
• Lead Sponsor: Gothenburg University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-14
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified