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Role of the Balano-preputial Furrow 's Microbiota, in Circumcised Patients or Not, in the Acquisition or Transmission of HIV

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ClinicalTrials.gov Identifier: NCT03985137
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The human immunodeficiency virus (HIV) remains at the moment a major public health problem. The figures currently report 37 million people infected with HIV worldwide, as well as 2 million new infections every year, the majority of which are men who have sex with men (MSM).

HIV research has accounted for more than 335,000 publications on PubMed since its first description in 1981. However, many questions remain unanswered, especially regarding the risk factors and protective factors, its transmission and acquisition, during sexual intercourse. By creating a background on PubMed with the keyword "HIV", we can see that at the end of the 80's, it was already established that male circumcision decreased the risk of transmission of HIV by 50 to 60%. Multiple hypotheses have been studied to justify this discovery, such as the reduction of micro-traumatisms, the modification of keratinization, the modification of penile anatomy induced by foreskin removal. In parallel, the rise of the study of the human microbiota, which refers to all microorganisms (bacteria, viruses, archaea, fungi and parasites) living in a specific environment, the human body, and this in a healthy or pathological situation. There is evidence that the microbiota may be involved in the pathogenesis of various diseases and may play a major role in the homeostasis of the human body. This implication has also interested researchers in the field of HIV : the protective role of circumcision in the acquisition and transmission of HIV has therefore begun to be studied in terms of the modification of the penile microbiome.

The first studies showed that circumcision had an impact on the abundance of bacteria present in the penis in humans, and modified the aerobic / anaerobic ratio in favor of the increase of aerobic bacteria. The first hypothesis was that circumcision played a protective role in the acquisition and transmission of HIV through a decrease in the diversity of the penile microbiota and in particular anaerobes.

This discovery was disrupted by the emergence of studies tending to question a microbiota predisposing to the risk of HIV acquisition in both men and women.

Indeed, it has been shown that certain bacteria (Prevotella, Dialister, ...) could favor the acquisition of the virus by the attraction in their wake of inflammation cells such as CD4 and Langerhans cells which would facilitate by their presence. , the penetration of the virus. This hypothesis has been proven in studies of bacterial vaginosis, which is known to be a risk factor for HIV acquisition and transmission. In 2012, results showed that the loss of Lactobacillus, in favor of anaerobic increases such as Gardnerella, Atopobium, and Prevotella, increased this risk against the HIV virus. Similarly, 7 bacteria have recently been incriminated in this phenomenon of susceptibility to HIV acquisition (Parvimonas, Gemella asaccharolytica, Mycoplasma hominis, Leptotrichia / Sneathia, Eggerthellaspecies and Megasphaeraspecies).Being committed to the exploration of the human microbiota in particular by culture, we propose to extend the knowledge of balano-preputial furrow 's microbiota in patients infected by HIV or not and supported in department Infectious Diseases. It is in this context, that a preliminary study carried out at the IHU between January and July 2018 made it possible to describe the existence of variability of the microbiota according to various criteria such as circumcision, HIV infection and sexual practices.


Condition or disease Intervention/treatment
HIV Infection Other: mucocutaneous sampling by swab at the balano-preputial furrow.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Role of the Balano-preputial Furrow 's Microbiota, in Circumcised Patients or Not, in the Acquisition or Transmission of HIV
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV-infected patients
Male patient presenting at a follow-up consultation for HIV infection or following a Sexual Viral Exposure (EVA) accident, pre-exposure prophylaxis (PrEP) or screening for a Sexually Transmitted Infection (IST).
Other: mucocutaneous sampling by swab at the balano-preputial furrow.
the sample is made by the patient




Primary Outcome Measures :
  1. prevalence rate of bacteria [ Time Frame: 12 months ]
    To compare the prevalence rate of bacteria between circumcised and uncircumcised patients by HIV or non-HIV status



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The participation of a patient in the study requires only one visit. This visit will take place during a medical consultation at the "Infectious and Tropical Diseases" department for one of the following reasons:

  • HIV treatment follow-up;
  • Sexual AEV follow-up;
  • STI Screening
  • Follow-up of ARV treatment under PrEP.
Criteria

Inclusion Criteria:

  • Major patient (18 years).
  • Male patient presenting at a follow-up consultation for HIV infection or following a Sexual Viral Exposure (EVA) accident, pre-exposure prophylaxis (PrEP) or screening for a Sexually Transmitted Infection (IST).
  • Person and / or legal guardian who has been informed of the study and has not expressed opposition to participate.
  • Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

  • Person having expressed his opposition to participate in the study.
  • Vulnerable person: person under tutorship or curatorship, or deprived of liberty by a judicial or administrative decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985137


Contacts
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Contact: Hervé Tissot-Dupont 33(0)4 13 73 20 11 herve.tissot-dupont@ap-hm.fr

Locations
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France
APHM Not yet recruiting
Marseille, Cedex 5, France, 13354
Contact: Hervé TISSOT DUPONT       herve.tissot-dupont@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD AP HM

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03985137     History of Changes
Other Study ID Numbers: 2019-24
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases