NCT05482854

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

30 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

January 3, 2022

Last Update Submit

September 28, 2023

Conditions

HIV Infections

Keywords

treatment interruptionHIV remissionPost-treatment controlHLA-B35Early treatment

Outcome Measures

Primary Outcomes (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.

    Six months after treatment interruption (Week 24).

Secondary Outcomes (14)

  • The acceptation rate of the trial by eligible patients

    At inclusion (Day 0)

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

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

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

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

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

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

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

    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)

  • +9 more secondary outcomes

Study Arms (1)

Patients treated early and carrying the MHC B35/53Bw4TTC2 Genotype

EXPERIMENTAL

Patients included in the ANRS CO6 PRIMO cohort, treated early and carrying the MHC B35/53Bw4TTC2 Genotype

Other: Analytical Treatment Interruption (ATI)

Interventions

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

Patients treated early and carrying the MHC B35/53Bw4TTC2 Genotype

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • Most recent CD4 measurement on cART above 500 cells/mm3
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • Planned absence which could prevent optimal trial participation (vacation abroad, moving, imminent job change ...).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, 13616, France

RECRUITING

Hôtel Dieu

Angers, 49033, France

WITHDRAWN

Hôpital Avicenne

Bobigny, 93000, France

ACTIVE NOT RECRUITING

Hôpital Saint-André

Bordeaux, 33075, France

ACTIVE NOT RECRUITING

Hôpital PELLEGRIN

Bordeaux, 33076, France

WITHDRAWN

Hôpital de la Côte de Nacre

Caen, 14033, France

WITHDRAWN

Hôpital Gabriel Montpied

Clermont-Ferrand, 63000, France

ACTIVE NOT RECRUITING

Hôpital Le Bocage

Dijon, 21034, France

RECRUITING

Hôpital Pierre Zobda-Quitman

Fort de France, 97261, France

ACTIVE NOT RECRUITING

Hôpital Raymond Poincaré

Garches, 92380, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85925, France

WITHDRAWN

Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94275, France

ACTIVE NOT RECRUITING

Hôpital de la Croix Rousse

Lyon, 69317, France

WITHDRAWN

Hôpital Edouard HERRIOT

Lyon, 69437, France

ACTIVE NOT RECRUITING

Hôpital Sainte Marguerite

Marseille, 13274, France

ACTIVE NOT RECRUITING

Hôpital Gui de Chauliac

Montpellier, 34295, France

ACTIVE NOT RECRUITING

Hôtel Dieu

Nantes, 44035, France

RECRUITING

Hôpital Carémeau

Nîmes, 30029, France

RECRUITING

Hôtel Dieu

Paris, 75004, France

WITHDRAWN

La Pitié Salpêtrière

Paris, 75013, France

WITHDRAWN

Institut Pasteur

Paris, 75015, France

WITHDRAWN

Hôpital de l'Hôtel-Dieu

Paris, 75181, France

RECRUITING

Hôpital Lariboisière

Paris, 75475, France

WITHDRAWN

Hôpital Saint-Louis

Paris, 75475, France

RECRUITING

Hôpital Tenon

Paris, 75970, France

WITHDRAWN

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

ACTIVE NOT RECRUITING

Hôpital de Purpan

Toulouse, 31059, France

RECRUITING

Hôpital Gustave Dron

Tourcoing, 59027, France

RECRUITING

Hôpital Bretonneau

Tours, 37044, France

ACTIVE NOT RECRUITING

CHI Villeneuve Saint Georges

Villeneuve-Saint-Georges, 94195, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Cécile GOUJARD

    Hôpital Bicêtre, Service de médecine interne et d'immunologie clinique

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent MEIFFREDY

CONTACT

00 33 1 45 59 52 06vincent.meiffredy@inserm.fr

Nicolas LETURQUE

CONTACT

00 33 1 45 59 51 93nicolas.leturque@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

August 1, 2022

Study Start

March 20, 2023

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(30)