The Effect of Arsenic Trioxide on Eliminating HIV-1 Reservoir Combined With cART
NCT ID: NCT03980665
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2019-04-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arsenic trioxide combined with cART
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.
Arsenic Trioxide
a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia
Without arsenic trioxide therapy
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.
No interventions assigned to this group
Interventions
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Arsenic Trioxide
a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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Guangzhou Institutes of Biomedicine and Health Chinese Academy of Sciences
UNKNOWN
Guangzhou 8th People's Hospital
OTHER
Responsible Party
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Linghua LI
Vice Chief physician
Principal Investigators
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Weiping Cai, Bachelor
Role: STUDY_CHAIR
Guangzhou 8th People's Hospital
Locations
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Guangzhou 8th People's Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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C
Role: backup
References
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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.
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.
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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.
Qiao L, Li Y, Xiong G, Liu X, He S, Tong X, Wu S, Hu H, Wang R, Hu H, Chen L, Zhang L, Wu J, Dai F, Lu C, Xiang Z. Effects of altered catecholamine metabolism on pigmentation and physical properties of sclerotized regions in the silkworm melanism mutant. PLoS One. 2012;7(8):e42968. doi: 10.1371/journal.pone.0042968. Epub 2012 Aug 24.
Abaza Y, Kantarjian H, Garcia-Manero G, Estey E, Borthakur G, Jabbour E, Faderl S, O'Brien S, Wierda W, Pierce S, Brandt M, McCue D, Luthra R, Patel K, Kornblau S, Kadia T, Daver N, DiNardo C, Jain N, Verstovsek S, Ferrajoli A, Andreeff M, Konopleva M, Estrov Z, Foudray M, McCue D, Cortes J, Ravandi F. Long-term outcome of acute promyelocytic leukemia treated with all-trans-retinoic acid, arsenic trioxide, and gemtuzumab. Blood. 2017 Mar 9;129(10):1275-1283. doi: 10.1182/blood-2016-09-736686. Epub 2016 Dec 21.
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Other Identifiers
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20170812V1
Identifier Type: -
Identifier Source: org_study_id
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