HUSH Restriction in HIV Infected Patients

December 17, 2021 updated by: ANRS, Emerging Infectious Diseases
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94270
        • Not yet recruiting
        • Hôpital Bicêtre
        • Contact:
      • Paris, France, 75015
        • Not yet recruiting
        • Hopital Necker
        • Contact:
      • Paris, France, 75004
        • Recruiting
        • Hôtel-Dieu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population infected either by HIV1 or HIV2

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viremia
Time Frame: Baseline
Intracellular HIV RNA load expressed in number of copies / ml
Baseline
Total HIV DNA and integrated HIV DNA
Time Frame: Baseline
Quantification by qPCR
Baseline
Hush activity
Time Frame: Baseline
Transcription rate of cellular genes targeted by HUSH by qRT-PCR
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS RF 004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe