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Chidamide in Combination With Antiretroviral Therapy for Eradication of the Latent HIV-1 Reservoir

NCT02513901 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-01-18

No results posted yet for this study

Summary

HIV replication can be effectively suppressed and acquired immunodeficiency syndrome(AIDS) can be prevented with highly active antiretroviral therapy (HAART). However, HIV-infected people must remain on treatment continuously to avoid viral rebound and progression to AIDS. HIV persistence is thought to stem primarily from the presence of integrated copies of the proviral genome within long-lived cells. Because active viral gene expression causes cell death due to viral cytopathic effects and the immune response, long-lived cells likely harbor transcriptionally silent, latent provirus. HIV-1 persistence in long-lived cellular reservoirs remains a major barrier to a cure. HDACi have the potential to activate ("Kick") these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response and antiretrovirals(ARVs) will be able to attack and eliminate ("Kill") the infected cells. The purpose of this study is to evaluate the safety and efficacy of multi-dose Chidamide in combination with antiretroviral therapy in HIV-infected adults with suppressed viral load.

Conditions

  • Chronic HIV Infections

Interventions

DRUG

Chidamide

Chidamide will be given by mouth on Day 0, 3, 7, 10, 14, 17, 21, 24.

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    collaborator INDUSTRY

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • Yongtao Sun, M.D., Ph.D. · Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513901 on ClinicalTrials.gov