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HUSH Restriction in HIV Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04172480
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Description
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Brief Summary:
HIV eradication faces a major obstacle that is viral persistence in latent reservoir cells despite antiretroviral therapy. Epigenetic repression plays a central role in viral transgene latency and several epigenetic regulators have been involved in this process. Among them, the "Human Silencing Hub" or HUSH complex, composed of Tasor, MPP8 and periphilin, has been shown to recruit the H3K9me3 methyltransferase "SET domain bifurcated 1" (SETDB1) and is therefore responsible for genes' epigenetic repression. Our recent results highlight the ability of Vpx from HIV-2/SIVsmm to counteract HUSH and to reactivate latent viruses in a latency model. We propose here to study HUSH activity along pathogenesis.

Condition or disease Intervention/treatment
HIV Infections Other: Blood sampling

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HUSH Restriction in HIV Infected Patients
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
acute HIV1 infection
Patient infected by HIV1, prior treatment initiation
 Other: Blood sampling
Peripheral blood sampling on EDTA
chronic HIV1 infection
Patient infected by HIV1, untreated or without treatment since at least 3 months
 Other: Blood sampling
Peripheral blood sampling on EDTA
HIV2 infection
Patient infected by HIV2, untreated or without treatment since at least 3 months
 Other: Blood sampling
Peripheral blood sampling on EDTA


Outcome Measures
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Primary Outcome Measures :
  1. Viremia [ Time Frame: Baseline ]
    Intracellular HIV RNA load expressed in number of copies / ml

  2. Total HIV DNA and integrated HIV DNA [ Time Frame: Baseline ]
    Quantification by qPCR

  3. Hush activity [ Time Frame: Baseline ]
    Transcription rate of cellular genes targeted by HUSH by qRT-PCR


Biospecimen Retention:   Samples With DNA
PBMC conserved in RLT Buffer for viral DNA and RNA extraction

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population infected either by HIV1 or HIV2
Criteria

Inclusion Criteria for group 1:

  • Symptomatic or asymptomatic acute HIV1 infection
  • Age above 15 years old
  • No ARV treatment prior inclusion (excepted as prophylaxis pre or post exposure)

Inclusion Criteria for group 2:

  • Chronic HIV1 infection
  • Age above 18 years old
  • No ARV treatment since at least 3 month (regardless the reason)

Inclusion Criteria for group 3:

  • HIV2 Infection
  • Age above 18 years old
  • No ARV treatment since at least 3 month (regardless the reason)

Exclusion Criteria for all groups:

  • HIV1 and HIV2 co-infection
  • Evolutive intercurrent pathology, in particular active co-infection (i.e. HBV, HCV, tuberculosis, HTLV1)
  • Life-threatening pathology
Contacts and Locations
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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): NCT04172480


Locations
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France
Hôpital Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Antoine CHERET, MD    1 45 21 25 77 ext 33    antoine.cheret@aphp.fr   
Hôtel-Dieu Recruiting
Paris, France, 75004
Contact: Jean-Paul VIARD, Pr    1 42 34 88 36 ext 33    jean-paul.viard@aphp.fr   
Hôpital Necker Not yet recruiting
Paris, France, 75015
Contact: Claudine DUVIVIER, MD    1 44 38 17 42 ext 33    duvivier@nck.aphp.fr   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
More Information
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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT04172480    
Other Study ID Numbers: ANRS RF 004
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 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