NCT02858414

Brief Summary

This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2017

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

July 29, 2016

Last Update Submit

December 5, 2018

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (2)

  • Measure of the integrated viral reservoir size

    Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.

    day 1

  • Measure of the proviral reservoir size

    Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells.

    day 1

Secondary Outcomes (1)

  • Measure of Akt activation

    day 1

Study Arms (1)

blood sample

EXPERIMENTAL
Other: additional blood sample

Interventions

additional blood sampleOTHER
blood sample

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment

You may not qualify if:

  • Age limits
  • Pregnancy
  • Legal restrictions to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Georges HERBEIN, MD-PhD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 8, 2016

Study Start

April 2, 2015

Primary Completion

October 4, 2017

Study Completion

October 4, 2017

Last Updated

December 6, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)