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Outcome Measures

Primary Outcomes (6)

Evolution of viral load of HIV RNA over the time frame of the study by ultrasensitive RT-qPCR
baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of cell-associated HIV RNA in PBMCs by qPCR. over the study time frame
baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of total DNA and episomal HIV DNA in lymphoid tissue (rectal biopsy)
Quantification by in-house virological assay
baseline, week 48, after resurgence of viremia in the analytical interruption of antiretrovirals, or after 24 and 96 weeks after analytical interruption of antiretrovirals.
Evolution of percentages of CD38 and HLA DR in CD4 + and CD8 + T lymphocytes
Measurement by flow cytometry of cell activation of CD4+ and CD8+ T lymphocytes as a means of assessing immune and inflammatory responses
baseline, weeks 12, 24, 36 and 48 and every 3 weeks after the antiretroviral ATI up to 36 months after antiretroviral ATI
Evolution of the HIV RNA sequence of the V3 region of gp 120, protease, reverse transcriptase and integrase regions of the pol gene, and of the gag gene

Interventions

intensified antiretroviral treatment using 2 NRTIs, dolutegravir, boosted darunavir/r, and maraviroc or Leronlimab, (ii) use of the HDACi nicotinamide Riboside or nicotinamide, and dendritic cell therapy using peptides of autologous HIV. After the intervention, participants will undergo analytical treatment interruption of antiretrovirals (ATI) and will be closely followed to monitor rebound of HIV viremia.

Multiple therapeutic interventions

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

\> 18 years old Documented HIV-1 infection. Has voluntarily signed ICF. On HAART ≥ 2 years, without changes in the 24 weeks immediately prior to screening.
HIV viral load \<50 copies/mL, and never \> 50 copies/mL on 2 consecutive occasions in the last 2 years. CD4 count nadir.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency Syndromes

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

NONE

Purpose

BASIC SCIENCE

Intervention Model

FACTORIAL

Model Details: We will apply an integrated, mechanistically complementary combination of therapeutic interventions to obtain sustained HIV remission without antiretrovirals. These approaches will include (i) intensified antiretroviral treatment using 2 NRTIs, dolutegravir, boosted darunavir/r, and maraviroc or Leronlimab, (ii) use of the HDACi nicotinamide Riboside or nicotinamide, and dendritic cell therapy using peptides of autologous HIV. After the intervention, participants will undergo analytical treatment interruption of antiretrovirals (ATI) and will be closely followed to monitor rebound of HIV viremia.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Professor

Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

Control

Multiple therapeutic interventions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Study Arms (2)

Control

Multiple therapeutic interventions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations