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

Guangzhou Medical University

Status and phase: Enrolling; Phase 1

Conditions: HIV/AIDS

Treatments: Drug: Arsenic Trioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03980665

20170812V1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arsenic trioxide combined with cART

Experimental group

Description:

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.

Treatment:

Drug: Arsenic Trioxide

Without arsenic trioxide therapy

No Intervention group

Description:

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.