NCT03298360

Brief Summary

To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

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

September 20, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

September 20, 2017

Last Update Submit

December 4, 2020

Conditions

HIV Infections

Keywords

HIV cell reservoir

Outcome Measures

Primary Outcomes (1)

  • Presence of HIV viral sequences in the CD32 + CD4a + T lymphocytes of the patients

    inclusion

Interventions

Blood sampleOTHER

167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV Infection

You may qualify if:

  • Patients who participated to ANRS139 TRIO trial, and still followed in centers
  • Who remained in virological success since the participation at the trial: 90% of HIV-1 RNA level less than 50 copies/mL : one or more blips less than 1000 copies/mL are tolerated
  • Genotypic resistance profiles available at baseline and before trial
  • Age ≥ 18 years
  • Affiliate or beneficiary of a social security system (the State Medical Aid or AME is not a social security system).
  • Written informed consent signed by the person and the investigator before any exam performed in the study.

You may not qualify if:

  • HIV-1 RNA level ≥ 1000 copies/mL at least once since the end of the 139 TRIO trial
  • Person under legal guardianship or deprived of liberty by a judicial or administrative decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monsef BENKIRANE

Montpellier, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

October 2, 2017

Study Start

June 28, 2018

Primary Completion

June 25, 2019

Study Completion

June 25, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

FR(1)