The Effect of Arsenic Trioxide on Eliminating HIV-1 Reservoir Combined With cART

Last updated: September 13, 2022
Sponsor: Guangzhou 8th People's Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv/aids

Aids And Aids Related Infections

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT03980665
20170812V1
  • Ages 18-60
  • All Genders

Study Summary

To evaluate the safety and efficacy of arsenic trioxide combined with cART in eliminating latent HIV-1 reservoir, providing potential strategies for AIDS functional cure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. HIV infection confirmed
  2. Receiving HAART more than 12 months.
  3. HIV viral-load < 50 copies/ml and CD4+ cell count more than 350 cells/ul.
  4. Without serious heart, lung, liver or kidney disease.
  5. Participants know about the study and sign informed consent.

Exclusion

Exclusion Criteria:

  1. With serious active HBV or HCV infection or opportunistic infections
  2. With serious chronic disease such as diabetes, mental illness,et al
  3. History of suffering from pancreatitis during HAART.
  4. Pregnant or breast-fed.
  5. With poor adherence.
  6. Unable to complete the follow up.

Study Design

Total Participants: 20
Study Start date:
April 01, 2019
Estimated Completion Date:
December 31, 2025

Study Description

Although combined antiretroviral therapy (cART) could control human immunodeficiency virus type 1 (HIV-1) infection, the persistence of HIV-1 viral reservoir make it extremely difficult to achieving cure of AIDS. The shock and kill strategy has been extensively practiced. The latency reversing agents (LRAs) could reactivate latent HIV-1 and then the reactivated virus could be eradicated. However, no appropriate activator has been found nor manufactured. Our previous work found that the arsenic trioxide, clinically approved for treating acute promyelocytic leukemia,could efficiently reactivate latent provirus in CD4+T cells from HIV-1 patients and Simian immunodeficiency virus (SIV)-infected macaques, without significant systemic T cell activation and inflammatory responses. In this study, we are going to study the safety of and efficacy of arsenic trioxide combined with cART in 20 HIV-1 infected patients, by observing adverse events,HIV-1 reservoir, HIV-1 load, and some immune index.

Connect with a study center

  • Guangzhou 8th People's Hospital

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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