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HUSH Restriction in HIV Infected Patients

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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)

Tracking Information
First Submitted Date November 19, 2019
First Posted Date November 21, 2019
Last Update Posted Date November 21, 2019
Actual Study Start Date October 1, 2019
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2019)
  • Viremia [ Time Frame: Baseline ]
    Intracellular HIV RNA load expressed in number of copies / ml
  • Total HIV DNA and integrated HIV DNA [ Time Frame: Baseline ]
    Quantification by qPCR
  • Hush activity [ Time Frame: Baseline ]
    Transcription rate of cellular genes targeted by HUSH by qRT-PCR
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HUSH Restriction in HIV Infected Patients
Official Title HUSH Restriction in HIV Infected Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
PBMC conserved in RLT Buffer for viral DNA and RNA extraction
Sampling Method Non-Probability Sample
Study Population Population infected either by HIV1 or HIV2
Condition HIV Infections
Intervention Other: Blood sampling
Peripheral blood sampling on EDTA
Study Groups/Cohorts
  • acute HIV1 infection
    Patient infected by HIV1, prior treatment initiation
    Intervention: Other: Blood sampling
  • chronic HIV1 infection
    Patient infected by HIV1, untreated or without treatment since at least 3 months
    Intervention: Other: Blood sampling
  • HIV2 infection
    Patient infected by HIV2, untreated or without treatment since at least 3 months
    Intervention: Other: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 19, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04172480
Other Study ID Numbers ANRS RF 004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators Not Provided
Investigators Not Provided
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date November 2019