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

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ClinicalTrials.gov Identifier: NCT03980665
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Guangzhou Institutes of Biomedicine and Health Chinese Academy of Sciences
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Drug: Arsenic Trioxide Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The control arm includes HIV-infected patients with the therapy of Antiretroviral drugs.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Arsenic Trioxide on Eliminating HIV-1 Reservoir Combined With cART
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic HIV/AIDS

Arm Intervention/treatment
Experimental: Arsenic trioxide combined with cART
Receiving intravenous arsenic trioxide, 0.16mg/kg/day, no more than 10 mg per-day , two to four weeks, combined with continuous cART after attaining plasma HIV-1 suppression (plasma HIV RNA <50 cp/ml) and CD4+ cell count more than 350 cells/ul over 1 year by cART, without active HCV or HBV infection or opportunistic infections.
Drug: Arsenic Trioxide
a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia
Other Name: Arsenic Trioxide Injectable Solution

No Intervention: Without arsenic trioxide therapy
Only receiving cART without arsenic Trioxide after attaining plasma HIV-1 suppression (plasma HIV RNA <50 cp/ml) and CD4+ cell count more than 350 cells/ul over 1 year by cART, without active HCV or HBV infection or opportunistic infections.



Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events of arsenic trioxide combined with cART [ Time Frame: 6 Months ]
    To observe the adverse events of arsenic trioxide combined with cART when treating with HIV-infected patients during the clinical trial


Secondary Outcome Measures :
  1. HIV-1 reservoir [ Time Frame: 6 Months ]
    To assay the HIV-1 viral load in the peripheral blood Mono-nuclear cells and plasma


Other Outcome Measures:
  1. HIV-specific immunity [ Time Frame: 6 Months ]
    The number of HIV-specific CD4,CD8 and their activity after receiving arsenic trioxide



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980665


Contacts
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Contact: Linghua Li, Doctor 020-83710825 llheliza@126.com
Contact: Weiping Cai, Bachelor 020-83710816 gz8hcwp@126.com

Locations
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China, Guangdong
Guangzhou 8th People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua LI, PhD    020-83710825    llheliza@126.com   
Contact: C         
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Guangzhou Institutes of Biomedicine and Health Chinese Academy of Sciences
Investigators
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Study Chair: Weiping Cai, Bachelor Guangzhou 8th People's Hospital

Publications:

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Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT03980665     History of Changes
Other Study ID Numbers: 20170812V1
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:
Arsenic Trioxide
cART
HIV-1 reservoir
functional cure

Additional relevant MeSH terms:
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Arsenic Trioxide
Antineoplastic Agents