NCT02771054

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

2.2 years

First QC Date

April 27, 2016

Last Update Submit

November 1, 2018

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

  • Reduction of CSF immune activation as measured by CSF neopterin

    12 months

  • Reduction of CSF immune activation as measured by CSF beta-2-microglobulin

    12 months

  • Reduction of CSF immune activation as measured by CSF immunoglobulin G index

    12 months

Secondary Outcomes (1)

  • Reduction of CSF HIV RNA levels, quantified with a Roche Cobas Taqman version 2 after ultracentrifugation from 10 mL (detection limit 1-2 copies/mL).

    12 months

Study Arms (1)

TAF/emtricitabine (FTC)

EXPERIMENTAL

All 20 patients will switch their nucleoside backbone, either ABC/3TC or TDF/FTC to TAF/FTC

Drug: TAF/FTC

Interventions

TAF/FTCDRUG

Change of nucleoside backbone

TAF/emtricitabine (FTC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurological symptoms or severe neurocognitive impairment
  • Pre-treatment CNS opportunistic infection/ tumour or HIV-associated dementia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 416 85, Sweden

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 12, 2016

Study Start

May 2, 2016

Primary Completion

July 15, 2018

Study Completion

July 15, 2018

Last Updated

November 5, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Locations

SE(1)