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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: Arsenic Trioxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection confirmed Receiving HAART more than 12 months. HIV viral-load < 50 copies/ml and CD4+ cell count more than 350 cells/ul. Without serious heart, lung, liver or kidney disease. Participants know about the study and sign informed consent. Exclusion Criteria: With serious active HBV or HCV infection or opportunistic infections With serious chronic disease such as diabetes, mental illness,et al History of suffering from pancreatitis during HAART. Pregnant or breast-fed. With poor adherence. Unable to complete the follow up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control arm includes HIV-infected patients with the therapy of Antiretroviral drugs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arsenic trioxide combined with cART<br>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<br>* a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia<br>* Other names: Arsenic Trioxide Injectable Solution;|
| No Intervention: Without arsenic trioxide therapy<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events of arsenic trioxide combined with cART | To observe the adverse events of arsenic trioxide combined with cART when treating with HIV-infected patients during the clinical trial | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 reservoir | To assay the HIV-1 viral load in the peripheral blood Mono-nuclear cells and plasma | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arsenic Trioxide, cART, HIV-1 reservoir, functional cure