Clinical trial NCT03980665: The Effect of Arsenic Trioxide on Eliminating HIV-1 Reservoir Combined With cART
Official title: The Effect of Arsenic Trioxide on Eliminating HIV-1 Reservoir Combined With cART
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: HIV/AIDS
Keywords: Arsenic Trioxide
cART
HIV-1 reservoir
functional cure
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Institutes of Biomedicine and Health Chinese Academy of Sciences
First posted: 2019-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control arm includes HIV-infected patients with the therapy of Antiretroviral drugs.
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events of arsenic trioxide combined with cART
timeFrame: 6 Months
Secondary outcomes:
measure: HIV-1 reservoir
timeFrame: 6 Months
Other outcomes:
measure: HIV-specific immunity
timeFrame: 6 Months
Locations:
city: Guangzhou
country: China
facility: Guangzhou 8th People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou 8th People's Hospital
name: Weiping Cai, Bachelor
role: STUDY_CHAIR
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