HIV/AIDS
Conditions
Keywords
Arsenic Trioxide, cART, HIV-1 reservoir, functional cure
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.
Interventions
DRUGArsenic Trioxide
a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia
Sponsors
Guangzhou Institutes of Biomedicine and Health Chinese Academy of Sciences
Guangzhou 8th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The control arm includes HIV-infected patients with the therapy of Antiretroviral drugs.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HIV-1 reservoir | 6 Months | To assay the HIV-1 viral load in the peripheral blood Mono-nuclear cells and plasma |
Other
| Measure | Time frame | Description |
|---|---|---|
| HIV-specific immunity | 6 Months | The number of HIV-specific CD4,CD8 and their activity after receiving arsenic trioxide |
Countries
China
Contacts
Primary ContactLinghua Li, Doctor
Backup ContactWeiping Cai, Bachelor
Outcome results
None listed