X-linked Biological Response to HIV Sensing: the ANRS EP 53 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Plasmacytoid dendritic cells (pDCs) are key actors of innate immunity that produce high levels of interferon (IFN)-alpha after activation of their Toll-Like Receptors (TLR) by pathogens. A difference between men and women has recently been shown in the level of IFN-alpha produced by pDCs after TLR activation. The production of IFN-alpha in response to TLR7 activation is higher in the presence of estrogens. This could be responsible for gender differences in the level of plasma HIV-1 RNA, that is lower in female as compared to male by about 50%, and for the sex-based differences in the susceptibility to HIV infection. Besides the role of estrogens, X-linked genetic factors could also be involved in the sex-dependent differences in the TLR7-mediated responses of pDCs. TLR7 gene is located on the X chromosome. A single nucleotide polymorphism (SNP) of the TLR7 gene, c.32A\>T, have been associated with accelerated disease progression in male HIV patients, and was found over represented in female HIV as well as HCV patients, suggesting that the T allele is associated with a gender-dependent increase of susceptibility to RNA virus infections. A peripheral blood sample will be collected from HIV-infected women 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.

Conditions

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Hiv Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HIV-infected women

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.

Group Type OTHER

A peripheral blood sample

Intervention Type BIOLOGICAL

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

Healthy control women

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

Group Type OTHER

A peripheral blood sample

Intervention Type BIOLOGICAL

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

Interventions

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A peripheral blood sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. HIV-infection through vertical or parenteral routes
2. Chronic infectious disease, notably HCV infection (hepatitis C virus)
3. Acute infectious disease
4. Auto-immune disease
5. Absence of social security (health insurance)
6. Pregnant or breastfeeding woman
7. Incapable adult

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes