NCT01895920

Brief Summary

This project aims at characterizing HIV-1 viral biofilms structural and functional properties and at deciphering its role as a new viral reservoir and as a new mode of viral spread. The prospective national study will be conducted on cells isolated from blood samples from 20 patients infected with HIV.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 27, 2018

Status Verified

May 1, 2017

Enrollment Period

5.1 years

First QC Date

July 2, 2013

Last Update Submit

February 26, 2018

Conditions

HIV Infection

Keywords

HIVBiofilmTransmission

Outcome Measures

Primary Outcomes (1)

  • The percentage of HIV positive patients with cells producing biofilms.

    2 years

Secondary Outcomes (1)

  • The number of cells with biofilms identified among the HIV positive patients presenting such structures.

    2 years

Study Arms (1)

HIV infection

EXPERIMENTAL

20 HIV infected subjects

Other: Blood sample

Interventions

Blood sampleOTHER
HIV infection

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • able to give written consent
  • HIV positive serology HIV1
  • Viral load \> 10 000 copies/ml
  • CD4 T cells \> 100 cells/mm3
  • or Treated by antiretroviral therapy (ARV) for less than 6 months
  • Covered by French Social Security

You may not qualify if:

  • Involved in a clinical trial
  • No covered by French Social Security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Interne, CHU Kremlin-Bicêtre

Le Kremlin-Bicêtre, 94270, 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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 11, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 27, 2018

Record last verified: 2017-05

Locations

FR(1)