NCT01520844

Brief Summary

A consortium of research teams has studied the immunovirological characteristics of these patients: The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 9, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

10.6 years

First QC Date

August 9, 2011

Last Update Submit

July 23, 2019

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

  • clinical and immuno-virological

    up to 5 years

Secondary Outcomes (4)

  • mechanisms leading to the virus control and CD4 homeostasy with physiopathological studies

    up to 5 years

  • impact of a prolonged untreated HIV infection,

    up to 5 years

  • frequency of the "immunological escapes" (CD4 T cell decrease) or "virological escapes" (permanent or transient viral load increase)

    up to 5 years

  • genetic characteristics of the patients and those of their viruses, the innate and adaptative immune responses directed against HIV and other viruses, the consequences of inflammation, and the characteristics of the loss of control

    up to 5 years

Study Arms (1)

Cohort study

OTHER

Blood sampling

Biological: blood sampling

Interventions

blood samplingBIOLOGICAL

blood sampling

Cohort study

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient infected with HIV-1 and not co-infected with HIV-2
  • Age ≥ 18 at enrollment
  • Able to give written consent
  • Covered by French Social Security
  • accept the constraints imposed by the study
  • without antiretroviral therapy for ALT, HIC and ALT HIC groups and a control of viral load after antiretroviral treatment interruption in PTC group
  • ALT group: Documented HIV-1 seropositive for at least 8 years with a CD4 count above 600/mm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years regardless of the viral load in the absence of antiretroviral treatment
  • HIC group: HIV-1 Seropositivity known for at least five years, asymptomatic, with the last 5 viral loads in HIV-RNA consecutive \<400 copies / mL regardless of CD4 count in the absence of antiretroviral treatment
  • ALT HIC group: HIV-1 seropositive known for at least 8 years and CD4 cell counts greater than 600/mm3 with a rate stable or increasing (positive or zero slope) on at least three consecutive examinations performed during the last 5 years and with the last 5 viral loads in HIV-RNA consecutive \<400 copies / mL in the absence of antiretroviral therapy.

You may not qualify if:

  • Under protection(saving) of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lambotte

Le Kremlin-Bicêtre, France

RECRUITING

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 Officials

  • Olivier Lambotte, Professor

    Kremlin Bicetre

    PRINCIPAL INVESTIGATOR

  • Laurence Meyer, Professor

    Methodologist INSERM CESP U1018

    STUDY CHAIR

Central Study Contacts

Olivier Lambotte, Professor

CONTACT

01 49 59 67 54olivier.lambotte@bct.aphp.fr

Faroudy Boufassa

CONTACT

01 45 21 23 65faroudy.boufassa@inserm.fr

Study Design

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

Study Record Dates

First Submitted

August 9, 2011

First Posted

January 30, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

FR(1)