AzTrials
AzTrials

HIV InfectionsNCT05482854

Assessment of HIV Remission Upon cART Interruption in Early Treated Individuals Carrying the MHC B35/53Bw4TTC2 Genotype

A study testing Analytical Treatment Interruption (ATI) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 30 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of the trial is to evaluate in ANRS CO6 PRIMO cohort participants if the presence of the MHC B35 (53) Bw4TTC2 genotype favors the control of HIV infection (defined by a viral load (VL) less than 400 cp/mL) after discontinuation of antiretroviral therapy (ART) initiated during primary HIV infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Analytical Treatment Interruption (ATI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
30 sitesFrance
Study dates
20 Mar 2023to Jul 2025
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years at the time of consent
  • Enrolled and currently followed in a site of the ANRS CO6 PRIMO Cohort
  • With the MHC genotype: at least one HLA B35 or B53 allele AND one HLA-A or B allele carrying the Bw4 epitope AND homozygous -21T residue in the HLA-B alleles AND heterozygous or homozygous for C2 epitope-carrying HLA-C alleles
  • Treated with cART within 3 months following inclusion in ANRS CO6 Primo Cohort during at least 18 months and cART not modified in the last 3 months
  • Controlled on cART: > 90% of VL below 50 cp/mL after initial virological response
  • All VL below 50 cp/mL during the previous 12 months
Show all 10Show fewer
  • Most recent CD4 measurement on cART above 500 cells/mm3
  • Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the study (article L1122-1-1 of the Public Health Code)
  • Person affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (State Medical Aid or AME is not a social security scheme)
  • Patient agreeing to participate in the trial according to the defined procedures.

Who cannot join

  • One VL above 1000 cp/mL on or off antitretrovirals after the initial viral control on antiretrovirals was achieved.
  • Patient on long-acting injectable HIV treatment
  • Patient in whom condom sex use or PrEP use by the partner will be difficult or impossible.
  • Woman with a pregnancy project and pregnant woman.
  • Patient under guardianship or curatorship.
  • History of a clinical AIDS event or cancer.
Show all 12Show fewer
  • Active HCV or HBV infection.
  • Any symptoms or laboratory values suggesting a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions, related to HIV or not, which contraindicates the interruption of ARVs.
  • Recent SARS-CoV-2 infection and / or associated with a drop in CD4 and / or associated with a resumption of CV in the last 6 months. In this situation, wait until the CD4 has returned to a rate > 500/mm3 and a CV < 50 copies / mL consolidated for > 6 months.
  • Affection, disability, resulting from a SARS-CoV-2 infection, regardless of the duration of the SARS-CoV-2 infection.
  • Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
  • Planned absence which could prevent optimal trial participation (vacation abroad, moving, imminent job change ...).

Trial locations and contacts

30 sites in 1 country.

Vincent MEIFFREDY contact

00 33 1 45 59 52 06

vincent.meiffredy@inserm.fr

Nicolas LETURQUE contact

00 33 1 45 59 51 93

nicolas.leturque@inserm.fr

30 sites in 1 country

France30 sites, 9 recruiting

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13616

    Christine FAUDON, cfaudon@ch-aix.fr

    Thierry ALLEGRE, MD

    Recruiting

  • Hôtel Dieu

    Angers, 49033

    Withdrawn

  • Hôpital Avicenne

    Bobigny, 93000

    Active, not recruiting

  • Hôpital Saint-André

    Bordeaux, 33075

    Active, not recruiting

  • Hôpital PELLEGRIN

    Bordeaux, 33076

    Withdrawn

  • Hôpital de la Côte de Nacre

    Caen, 14033

    Withdrawn

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000

    Active, not recruiting

  • Hôpital Le Bocage

    Dijon, 21034

    Carole CHARLES, carole.charles@chu-dijon.fr

    Lionel PIROTH, PhD

    Recruiting

  • Hôpital Pierre Zobda-Quitman

    Fort de France, 97261

    Active, not recruiting

  • Hôpital Raymond Poincaré

    Garches, 92380

    Rezak MAHREZ, rezak.mahrez@aphp.fr

    Pierre DE TRUCHIS, MD

    Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925

    Withdrawn

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275

    Active, not recruiting

  • Hôpital de la Croix Rousse

    Lyon, 69317

    Withdrawn

  • Hôpital Edouard HERRIOT

    Lyon, 69437

    Active, not recruiting

  • Hôpital Sainte Marguerite

    Marseille, 13274

    Active, not recruiting

  • Hôpital Gui de Chauliac

    Montpellier, 34295

    Active, not recruiting

  • Hôtel Dieu

    Nantes, 44035

    Morane CAVELLEC, Morane.CAVELLEC@chu-nantes.fr

    François RAFFI, PhD

    Recruiting

  • Hôpital Carémeau

    Nîmes, 30029

    Régine DONCESCO, regine.doncesco@chu-nimes.fr

    Didier LAUREILLARD, MD

    Recruiting

  • Hôtel Dieu

    Paris, 75004

    Withdrawn

  • La Pitié Salpêtrière

    Paris, 75013

    Withdrawn

  • Institut Pasteur

    Paris, 75015

    Withdrawn

  • Hôpital de l'Hôtel-Dieu

    Paris, 75181

    Marie-Josée DULUCQ, marie-josee.dulucq@aphp.fr

    Jean-Paul VIARD, PhD

    Recruiting

  • Hôpital Lariboisière

    Paris, 75475

    Withdrawn

  • Hôpital Saint-Louis

    Paris, 75475

    Jeannine DELGADO, jeannine.delgado@aphp.fr

    Jean-Michel MOLINA, PhD

    Recruiting

  • Hôpital Tenon

    Paris, 75970

    Withdrawn

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

    Active, not recruiting

  • Hôpital de Purpan

    Toulouse, 31059

    Sandra LAGARRIGUE, lagarrigue.s@chu-toulouse.fr

    Pierre DELOBEL, PhD

    Recruiting

  • Hôpital Gustave Dron

    Tourcoing, 59027

    Pauline CORNAVIN, pcornavin@ch-tourcoing.fr

    Olivier ROBINEAU, PhD

    Recruiting

  • Hôpital Bretonneau

    Tours, 37044

    Active, not recruiting

  • CHI Villeneuve Saint Georges

    Villeneuve-Saint-Georges, 94195

    Active, not recruiting

Other trials in France

About this study

Official title: ANRS 175 RHIVIERA-01: Assessment of HIV Remission Upon Combination Antiretroviral Therapy (cART) Interruption in Early Treated Individuals From ANRS CO6 PRIMO Cohort Carrying the Major Histocompatibility Complex (MHC) B35/53Bw4TTC2 Genotype

The aim of the trial is to evaluate in ANRS CO6 PRIMO cohort participants if the presence of the MHC B35 (53) Bw4TTC2 genotype favors the control of HIV infection (defined by a viral load (VL) less than 400 cp/mL) after discontinuation of antiretroviral therapy (ART) initiated during primary HIV infection.

The trial will be a pilot "proof of concept", one arm, multicenter, nested in the ANRS CO6 PRIMO Cohort, in which the intervention is treatment interruption (of at least 6 months).

It is planned to include between 20 and 50 participants.

Read the detailed description

The ANRS 175 RHIVIERA 01 trial will focus on people who were initiated early and have a particular genotypic profile associated with HIV remission.

The study proposes to test an intervention consisting in a ART-treatment interruption (of at least 6 months) in ANRS CO6 PRIMO cohort participants carrying the MHC B35/53Bw4TTC2 genotype and well controlled on cART.

The study aims to enrol 20-30 participants in 30 French clinical sites. Participants will be enrolled after checking eligibility criteria and will interrupt ART immediatly after inclusion.

Control of HIV-Infection, defined by a viral load less than 400 cp/mL, will be evaluated after 24 weeks of interruption.

Study duration will vary by participant, depending on the time of ART interruption and the time to viral rebound. Participants will be followed maximum 48 weeks on ATI. If there is a viral rebound justifying the resumption of ART, participant will be followed 24 weeks maximum after resumption. The maximum duration of the study will be 48+24 = 72 weeks.

Conditions
HIV Infections
Being tested
Analytical Treatment Interruption (ATI)
Keywords
treatment interruption, HIV remission, Post-treatment control, HLA-B35, Early treatment
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Analytical Treatment Interruption (ATI)Other

    Analytical Interruption of Treatment for 24-48 weeks

    ART resumption and follow-up for 24 weeks if the participant meets at least one ART resumption criteria

Study groups in NCT05482854
Study groupRoleWhat they receive
Patients treated early and carrying the MHC B35/53Bw4TTC2 GenotypeExperimentalPatients included in the ANRS CO6 PRIMO cohort, treated early and carrying the MHC B35/53Bw4TTC2 Genotype
Receives: Other: Analytical Treatment Interruption (ATI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with a Plasma HIV-1 RNA (viral load,VL) below 400 copies/mL at 6 months after Treatment interruption (Week 24).

    Proportion of subjects with a Plasma HIV-1 RNA below 400 copies/mL on subjects included at 6 months after Treatment interruption.

    Measured: Six months after treatment interruption (Week 24).

Secondary outcomes (14)

  1. The acceptation rate of the trial by eligible patients

    Percentage of patients who accept to participate on patients pré-screened and eligible

    Measured: At inclusion (Day 0)

  2. Proportion of patients with a plasma VL < 50 copies/ml at 3 and 6 months following Analytic Treatment Interruption (ATI)

    Proportion of patients with a plasma VL < 50 copies/ml at 3 and 6 months following ATI

    Measured: At 3 months (week 12) and 6 months (week 24) following ATI

  3. Evolution of number of CD4 T cells count during ATI and after ART resumption

    Measurement of CD4 T cells count at Screening, Day 0, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 48, Day 0 ART resumption, Week 4 resumption, Week 12 resumption, Week 24 resumption

    Measured: During all ATI period (from Day 0 to Day 0 ART resumption - maximum 48 weeks) and during ART resumption period (maximum 24 Weeks)

  4. Evolution of CD4 to CD8 ratio during ATI and after ART resumption

    Measurement of CD4 to CD8 at Screening, Day 0, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 48, Day 0 ART resumption, Week 4 resumption, Week 12 resumption, Week 24 resumption

    Measured: During all ATI period (from Day 0 to Day 0 ART resumption - maximum 48 weeks) and during ART resumption period (maximum 24 Weeks)

  5. Evolution of total and integrated HIV DNA and cell-associated HIV RNA transcripts

    Quantification of total HIV-DNA and integrated HIV-DNA by ultrasensitive techniques (ultrasensitive real-time PCR and Alu PCR) Quantification of intracellular HIV-RNA transcripts by ultrasensitive technique (ultrasensitive qPCR gag).

    Measured: During ATI period (At Day 0, Week 4, Week 12, Week 24) and during ART resumption period (at Day 0 Resumption, and Week 24 ART Resumption)

  6. Evolution of HIV markers in sperm (on 25 participants)

    Quantification of HIV DNA on semen cells (ultrasensitive technique) and quantification of HIV RNA on seminal fluid (ultrasensitive technique)

    Measured: During ATI period (At Day 0, Week 4, Week 12, Week 24) and at Day 0 ART resumption

  7. Evolution of the levels of inflammation markers during ATI

    Physiological parameters levels will be studied (Luminex and Simoa technology): IFNα, TGFβ, IL-7, IL-12, IL-15, IL-18, IP-10, DPPIV, ARNr 16S, I-FABP, citrulline, sCD14, sCD163

    Measured: During ATI period (up to week 24 ATI) and at Day 0 ART resumption

  8. Proportion of patients who resumed treatment during the first 6 months of ATI, according to the reasons for resuming

    Percentage of resumption, according to the reasons listed in the protocol, before the evaluation of the primary outcome

    Measured: At week 24

  9. Pharmacological dosages of antiretrovirals performed during the ATI from frozen samples

    Pharmacological dosages of antiretrovirals performed during the ATI at Week 2 and Week 24 of ATI

    Measured: At Week 2 and Week 24 of ATI

  10. Proportion of patients reporting at each visit to use condoms

    Document the emphasis being placed on the impact of access to information on prevention behaviors and the quality of sexual life.

    Measured: From date of inclusion to the last follow-up visit, up to 72 weeks (average of 1 year).

  11. Proportion of patients reporting at each visit to have proposed PrEP at their partners

    Document the emphasis being placed on the impact of access to information on prevention behaviors and the quality of sexual life.

    Measured: From date of inclusion to the last follow-up visit, up to 72 weeks (average of 1 year).

  12. Proportion of patients satisfied with their participation at the end of the trial

    Through statistical analyses of some self-administered questionnaires items (Likert).

    On a Likert scale, a person selects one option among several that reflects how much they agree with a statement. The scale generally consists of five or seven balanced responses that people can choose from.

    Measured: Questionnaire at the end of the study (Week 48 ou Week 24 resumption). Questionnaire at screening (in case of refusal to participate)

  13. Evolution of the level of the quality of life between inclusion and the end of the trial

    Through statistical analyses of some self-administered questionnaires items ( SF12.v2 scale for quality of life). The 12-item Short-Form Health Survey is a widely used, generic patient-reported measure of health status that provides summary scores of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

    Measured: Questionnaire at Day 0, at Week 24 (or resumption of ART) and at the end of the study (Week 48 ou Week 24 resumption). Questionnaire at screening (in case of refusal to participate)

  14. Evolution of the global satisfaction with sexual life between inclusion and the end of the trial

    Through statistical analyses of some self-administered questionnaires items (Likert).

    On a Likert scale, a person selects one option among several that reflects how much they agree with a statement. The scale generally consists of five or seven balanced responses that people can choose from.

    Measured: Questionnaire at Day 0, at Week 24 (or resumption of ART) and at the end of the study (Week 48 ou Week 24 resumption). Questionnaire at screening (in case of refusal to participate)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2022
  2. Study start20 Mar 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
The trial will be a pilot "proof of concept", one arm, multicenter, nested in the ANRS CO6 PRIMO Cohort, in which the intervention is treatment interruption (of at least 6 months).
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05482854
Sponsor's protocol ID
ANRS 175 RHIVIERA-01
Status last verified
Sep 2023
First submitted
3 Jan 2022
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Analytical Treatment Interruption (ATI) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 30 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 10 inclusion and 12 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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?

Contact Vincent MEIFFREDY (00 33 1 45 59 52 06, vincent.meiffredy@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with a Plasma HIV-1 RNA (viral load,VL) below 400 copies/mL at 6 months after Treatment interruption (Week 24). (time frame: Six months after treatment interruption (Week 24).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05482854.

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 29 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in