HIV InfectionsNCT04172480
HUSH Restriction in HIV Infected Patients
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood sampling
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Oct 2019to 30 Sep 2023
- Phase
- Observational
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population infected either by HIV1 or HIV2
Who may be able to join
- Symptomatic or asymptomatic acute HIV1 infection
- Age above 15 years old
- No ARV treatment prior inclusion (excepted as prophylaxis pre or post exposure)
- Chronic HIV1 infection
- Age above 18 years old
- No ARV treatment since at least 3 month (regardless the reason)
Show all 9Show fewer
- HIV2 Infection
- Age above 18 years old
- No ARV treatment since at least 3 month (regardless the reason)
Who cannot join
- HIV1 and HIV2 co-infection
- Evolutive intercurrent pathology, in particular active co-infection (i.e. HBV, HCV, tuberculosis, HTLV1)
- Life-threatening pathology
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Antoine CHERET, MD, 1 45 21 25 77 ext. 33, antoine.cheret@aphp.fr
- Recruiting
Hôtel-Dieu
Paris, 75004
Jean-Paul VIARD, Pr, 1 42 34 88 36 ext. 33, jean-paul.viard@aphp.fr
- Not yet recruiting
Hôpital Necker
Paris, 75015
Claudine DUVIVIER, MD, 1 44 38 17 42 ext. 33, duvivier@nck.aphp.fr
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Blood sampling
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Peripheral blood sampling on EDTA
| Study group | Role | What they receive |
|---|---|---|
| acute HIV1 infection | Patient infected by HIV1, prior treatment initiation Receives: Other: Blood sampling | |
| chronic HIV1 infection | Patient infected by HIV1, untreated or without treatment since at least 3 months Receives: Other: Blood sampling | |
| HIV2 infection | Patient infected by HIV2, untreated or without treatment since at least 3 months Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viremia
Intracellular HIV RNA load expressed in number of copies / ml
Measured: Baseline
Total HIV DNA and integrated HIV DNA
Quantification by qPCR
Measured: Baseline
Hush activity
Transcription rate of cellular genes targeted by HUSH by qRT-PCR
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172480
- Sponsor's protocol ID
- ANRS RF 004
- Status last verified
- Dec 2021
- First submitted
- 19 Nov 2019
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUSH Restriction in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT04172480
- Acronym / sponsor ID
- ANRS RF 004
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Nov 2019 (actual)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acute HIV1 infection | – | Other: Blood samplingPatient infected by HIV1, prior treatment initiation |
| chronic HIV1 infection | – | Other: Blood samplingPatient infected by HIV1, untreated or without treatment since at least 3 months |
| HIV2 infection | – | Other: Blood samplingPatient infected by HIV2, untreated or without treatment since at least 3 months |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population infected either by HIV1 or HIV2
Key inclusion criteria (9 listed)
- Symptomatic or asymptomatic acute HIV1 infection
- Age above 15 years old
- No ARV treatment prior inclusion (excepted as prophylaxis pre or post exposure)
- Chronic HIV1 infection
- Age above 18 years old
Key exclusion criteria (3 listed)
- HIV1 and HIV2 co-infection
- Evolutive intercurrent pathology, in particular active co-infection (i.e. HBV, HCV, tuberculosis, HTLV1)
- Life-threatening pathology
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 |
|---|---|---|
| Blood samplingPeripheral blood sampling on EDTA | Other | HIV2 infection, acute HIV1 infection, chronic HIV1 infection |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by ANRS, Emerging Infectious Diseases at 3 sites 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viremia (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2021.