Evaluation of Innovative Combinatorial stratégies of Anti-latency and Anti-immune Activation Drugs Targeting HIV Reservoir

NCT04741100 | Withdrawn

• 1 other identifier: CREPATS 04
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Several barriers prevent the remission of HIV infection: low level viremia, HIV latency in the genome of host infected immune cells and persistent immune activation. Targeting immune activation and viral latency, represent the two intimately intricate goals to be envisaged for purging the reservoir, in the perspective of HIV cure. There is an urgent to develop and to test drugs targeting HIV latency, HIV residual replication and immune activation, alone or in synergistic combinations. We propose in this study to test agents with a potential effect on HIV latency by combining classical agents and newly discovered agents. The Pitié-Salpêtrière virology group has identified some new diaminopiperidine based compounds that have some antilatency properties through an activation of transcription. Compounds of this new class will be tested in combination with classical agents (HDAC inhibitors, HMT inhibitors, inducers of P-TEFb release, PKC agonists, DNMT inhibitors) and less toxic compounds from classical categories for which Carine Van Lint (University of Brussels) has obtained preliminary HIV reactivation data. All the experimentations will be conducted in J-Lat cells and in ex- vivo CD4 cells sampled in patients from the Pitié-Salpêtrière HIV cohort.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Primary outcome Measure

  Measure the new anti-latency drugs to assess ex vivo the synergistic effects of from different families in different cells

  18 months

Interventions

Ex-vivo analysis OTHER

Ex-vivo analysis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients HIV infected on suppressive cART

You may qualify if:

• Documented HIV-1 infection
• CD4+ count nadir ≥ 200 cells/mm3
• At least 4 years of suppressive ART, i.e. HIV plasma viral load (RNA) ≤ 50 copies/ml without any interruption (less than one month cumulative);1 blip/year allowed at values of maximum 1000 cp/ml
• Ability and willingness to provide informed consent

You may not qualify if:

• Active HBV and/or HCV co-infection
• Pregnancy or breast-feeding woman
• Previous immunotherapy (e.g. IL-2, IL-7) within the past year
• Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
• History of autoimmune disease, such as systemic lupus erythematosis (SLE) or Hashimoto's thyroiditis
• Active drug or alcohol use or dependence that, in the opinion of the center investigator, would interfere with adherence to study requirements.

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Officials

• Christine Katlama, MD

  Pitie-Salpetriere Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: September 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02