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

Phase 1

Recruiting

• Conditions: HIV/AIDS
• Interventions: Drug: Arsenic Trioxide

• Registration Number: NCT03980665
• Lead Sponsor: 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.

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 reactiva...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arsenic trioxide combined with cART	Arsenic Trioxide	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.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events of arsenic trioxide combined with cART	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

Name	Time	Method
HIV-1 reservoir	6 Months	To assay the HIV-1 viral load in the peripheral blood Mono-nuclear cells and plasma

Trial Locations

Locations (1)

Guangzhou 8th People's Hospital; 🇨🇳 Guangzhou, Guangdong, China