NCT04720742

Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation

Name: Clinical Trial NCT04720742
Creator: IrsiCaixa
Keywords: HIV Infection, Analytical Treatment Interruption + bNAbs infusion, Phase 2, drug, clinical trial, Italy,Netherlands,Spain

Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation (ITATI)

IrsiCaixa·Phase 2·ClinicalTrials.gov·drugSuspended

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Study focus

Disease/Condition: HIV Infection
Drug/Device/Intervention: Analytical Treatment Interruption + bNAbs infusion
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: IrsiCaixa
Location: Milan,Utrecht,Granada,Madrid, Italy,Netherlands,Spain

Timeline & enrollment

Phase: Phase 2
Start date: Feb 28, 2021
End date: Mar 01, 2022
Enrollment: 5 participants

Primary outcome

Time to reappearance of HIV-1 viremia,Time to reappearance of HIV-1 replication competent reservoir,Time to reappearance of HIV-1 total reservoir

Summary

The availability of antiretroviral therapy (cART) for HIV-1 infection has led to a reduction in morbidity in patients with chronic HIV infection. However, cART does not eliminate HIV-1 that persists as a latent infection in cellular reservoirs. Usually, HIV viremia rapidly rebounds if antiretroviral therapy is interrupted. Consequently, HIV infected individuals must commit to expensive, life-long therapies and must tackle problems associated with chronic infection and uninterrupted cART, including continuous clinical and laboratory monitoring, drug toxicities, and chronic immune activation/inflammation.  Currently, there is an emerging interest in developing safe and affordable curative strategies that would eliminate the need for lifelong therapy. However, to date only allogeneic hematopoietic stem cell transplantation (allo-HSCT) has shown results in decreasing the HIV-1 reservoirs.  The IciStem Consortium (www.icistem.org) has assembled the largest and most exhaustive observational cohort for the study of HIV reservoir dynamics in allo-HSCT HIV+ individuals with severe hematological malignancies worldwide. Within the cohort, only individuals transplanted with a donor with thw CCR5A32 mutation have shown signs of HIV remission. On the other side broadly neutralizing antibodies (bNAbs) have shown the potential to control HIV infection. This study intends to evaluate if the allo-HSCT combined with the additional application of bNAbs is effective to control HIV replication.

ICD-10 classifications

HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04720742
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT04720742 through Pure Global AI's free database. This Phase 2 trial is sponsored by IrsiCaixa and is currently Suspended. The study focuses on HIV Infection. Target enrollment is 5 participants.

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