Hiv InfectionX LIBRISNCT01952587
X-linked Biological Response to HIV Sensing: the ANRS EP 53 Study
A study testing A peripheral blood sample in people with Hiv Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv Infection
- What is being tested?
- A peripheral blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency and Functional Impact of the c.32A>T Genetic Polymorphism of TLR7 in Women Infected With HIV-1 : the ANRS EP53 Study
Short title :
X-linked biological response to HIV sensing: the ANRS EP 53 study.
Read more
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.
Read the detailed description
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
- Hiv Infection
- Being tested
- A peripheral blood sample
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Biological: A peripheral blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (1)
Frequency (%) of cells expressing the "A" and "T" alleles of TRL7 in interferon-alpha producing cells
Measured: day 1 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hiv InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952587
- Sponsor's protocol ID
- ANRS EP 53 X LIBRIS
- Other IDs
- 2013-A00954-41
- Acronym
- X LIBRIS
- Status last verified
- Jun 2015
- First submitted
- 5 Aug 2013
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32554924
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Functional Impact of the c.32A>T Genetic Polymorphism of TLR7 in Women Infected With HIV-1 : the ANRS EP53 Study
- ClinicalTrials.gov ID
- NCT01952587
- Acronym / sponsor ID
- X LIBRIS / ANRS EP 53 X LIBRIS
- Conditions
- Hiv Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected women | Other | Biological: A peripheral blood sampleA 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. |
| Healthy control women | Other | Biological: A peripheral blood sampleA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A peripheral blood sampleA 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 | Biological | HIV-infected women, Healthy control women |
Primary outcome
Frequency (%) of subjects carrying the TRL7 c.32A>T SNP in HIV-infected and healthy women
Time frame: day 1
arguing in favor of role of impaired production of IFN alpha by pDCs in the risk of becoming infected by HIV 1
1 secondary outcome
Frequency (%) of cells expressing the "A" and "T" alleles of TRL7 in interferon-alpha producing cells
Time frame: day 1 and month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 32554924Azar 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A peripheral blood sample in people with Hiv Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency (%) of subjects carrying the TRL7 c.32A>T SNP in HIV-infected and healthy women (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.