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| Name | Class |
|---|---|
| Guangzhou Institutes of Biomedicine and Health Chinese Academy of Sciences | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arsenic trioxide combined with cART | Experimental | 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. |
|
| Without arsenic trioxide therapy | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arsenic Trioxide | Drug | a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-specific immunity | The number of HIV-specific CD4,CD8 and their activity after receiving arsenic trioxide | 6 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linghua Li, Doctor | Contact | 020-83710825 | llheliza@126.com | |
| Weiping Cai, Bachelor | Contact | 020-83710816 | gz8hcwp@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiping Cai, Bachelor | Guangzhou 8th People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou 8th People's Hospital | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26588898 | Background | Liu C, Ma X, Liu B, Chen C, Zhang H. HIV-1 functional cure: will the dream come true? BMC Med. 2015 Nov 20;13:284. doi: 10.1186/s12916-015-0517-y. | |
| 9671771 | Background | Chun TW, Engel D, Berrey MM, Shea T, Corey L, Fauci AS. Early establishment of a pool of latently infected, resting CD4(+) T cells during primary HIV-1 infection. Proc Natl Acad Sci U S A. 1998 Jul 21;95(15):8869-73. doi: 10.1073/pnas.95.15.8869. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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The control arm includes HIV-infected patients with the therapy of Antiretroviral drugs.
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| 9360927 | Background | Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295. |
| 9371822 | Background | Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193. |
| 9360926 | Background | Wong JK, Hezareh M, Gunthard HF, Havlir DV, Ignacio CC, Spina CA, Richman DD. Recovery of replication-competent HIV despite prolonged suppression of plasma viremia. Science. 1997 Nov 14;278(5341):1291-5. doi: 10.1126/science.278.5341.1291. |
| 23375003 | Background | Donahue DA, Wainberg MA. Cellular and molecular mechanisms involved in the establishment of HIV-1 latency. Retrovirology. 2013 Feb 1;10:11. doi: 10.1186/1742-4690-10-11. |
| 15286729 | Background | Goulder PJ, Watkins DI. HIV and SIV CTL escape: implications for vaccine design. Nat Rev Immunol. 2004 Aug;4(8):630-40. doi: 10.1038/nri1417. No abstract available. |
| 19487423 | Background | Goonetilleke N, Liu MK, Salazar-Gonzalez JF, Ferrari G, Giorgi E, Ganusov VV, Keele BF, Learn GH, Turnbull EL, Salazar MG, Weinhold KJ, Moore S; CHAVI Clinical Core B; Letvin N, Haynes BF, Cohen MS, Hraber P, Bhattacharya T, Borrow P, Perelson AS, Hahn BH, Shaw GM, Korber BT, McMichael AJ. The first T cell response to transmitted/founder virus contributes to the control of acute viremia in HIV-1 infection. J Exp Med. 2009 Jun 8;206(6):1253-72. doi: 10.1084/jem.20090365. Epub 2009 Jun 1. |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |