NCT01952587

Brief Summary

Short title : X-linked biological response to HIV sensing: the ANRS EP 53 study. Main outcome : To demonstrate that HIV-infected women carry the TLR7 c.32A\>T SNP at a higher frequency than uninfected women, arguing in favor of a role of impaired production of IFN-alpha by pDCs in the risk of becoming infected by HIV-1. Secondary outcome : To directly demonstrate at a single cell level that the TLR7 c.32A\>T SNP is responsible for a reduce production of IFN-alpha by pDCs after activation of TLR7 by HIV-1 RNA. Short abstract (public dissemination) : Male and female display some differences in how their immune system responds to pathogens. This could be related to hormonal or genetic factors located on the X chromosome. This project aims at characterizing X-linked factors that can influence the innate immune response to HIV-1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

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

August 5, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 23, 2026

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

August 5, 2013

Last Update Submit

April 21, 2026

Conditions

Hiv Infection

Outcome Measures

Primary Outcomes (1)

  • Frequency (%) of subjects carrying the TRL7 c.32A>T SNP in HIV-infected and healthy women

    arguing in favor of role of impaired production of IFN alpha by pDCs in the risk of becoming infected by HIV 1

    day 1

Secondary Outcomes (1)

  • Frequency (%) of cells expressing the "A" and "T" alleles of TRL7 in interferon-alpha producing cells

    day 1 and month 3

Study Arms (2)

HIV-infected women

OTHER

A peripheral blood sample will be collected from HIV-infected women to measure TLR-7 SNP frequency by PCR. IFN-alpha production from pDCs after HIV-1 RNA sensing by TLR7 will also be assessed.

Biological: A peripheral blood sample

Healthy control women

OTHER

A peripheral blood sample will be collected from healthy women to measure TLR-7 SNP frequency by PCR. IFN-alpha production from pDCs after HIV-1 RNA sensing by TLR7 will also be assessed

Biological: A peripheral blood sample

Interventions

A peripheral blood sampleBIOLOGICAL

A peripheral blood sample will be collected from HIV-infected subjects and healthy control to measure TLR-7 SNP frequency by PCR. IFN-alpha production from pDCs after HIV-1 RNA sensing by TLR7 will also be assessed

HIV-infected womenHealthy control women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian Female
  • HIV-1 infection (ELISA and western-blot tests)
  • HIV-infection through the sexual route before 50 years-old
  • Continuous antiretroviral therapy for more than 6 months
  • Plasma HIV-1 RNA \<50 copies/ml in the last 6 months
  • Age \>18-year old
  • Health insurance
  • Informed consent

You may not qualify if:

  • HIV-infection through vertical or parenteral routes
  • Chronic infectious disease, notably HCV infection (hepatitis C virus)
  • Acute infectious disease
  • Auto-immune disease
  • Absence of social security (health insurance)
  • Pregnant or breastfeeding woman
  • Incapable adult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purpan Hospital

Toulouse, France

Location

Related Publications (1)

  • Azar P, Mejia JE, Cenac C, Shaiykova A, Youness A, Laffont S, Essat A, Izopet J, Passaes C, Muller-Trutwin M, Delobel P, Meyer L, Guery JC. TLR7 dosage polymorphism shapes interferogenesis and HIV-1 acute viremia in women. JCI Insight. 2020 Jun 18;5(12):e136047. doi: 10.1172/jci.insight.136047.

    PMID: 32554924RESULT

Related Links

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

September 30, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 23, 2026

Record last verified: 2015-06

Locations

FR(1)