NCT02648516|UnknownPhase 1/2DMC
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Sponsor study identifier
interventional
20
1 country
1
Study Start
October 2016
Actual (reported)Primary Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Combination antiretroviral therapy (ART) effectively suppresses viral replication, leading to a significant immune recovery and a dramatic reduction in the incidence of AIDS-defining events. However, approximately 20% of individuals who exhibit stable viral suppression by ART, but fail to achieve sufficient immune reconstitution and are considered immune nonresponders (INRs). These INRs often experience an increased risk of opportunistic infections and shorter life expectancy compared with matched immune responders.Therefore, efficiently treating these immune nonresponders has become one of the most difficult challenges in the clinic.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 8, 2015
Actual (reported)January 7, 2016
Actual (reported)October 2016
Actual (reported)July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The changes of CD4 T cell counts
marker for host immunity
At Baseline and week 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
The changes of HIV-1 DNA
At Baseline and up to week 96
The ratio of CD4 and CD8 T cells
At Baseline and week 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
At Baseline and up to week 96
Participants will receive ART plus a dose of allogenic adoptive immune transfusion (3 times of MNCs transfusions) from day 0 through the week 2 study visit.
Participants will receive ART and taken i.v., at a dose of 2-3\*10E8 MNCs/kg body at baseline, week 1 and 2.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing 302 hospital
Beijing, Beijing Municipality, 100069, China
Zhang Z, Fu J, Xu X, Wang S, Xu R, Zhao M, Nie W, Wang X, Zhang J, Li T, Su L, Wang FS. Safety and immunological responses to human mesenchymal stem cell therapy in difficult-to-treat HIV-1-infected patients. AIDS. 2013 May 15;27(8):1283-93. doi: 10.1097/QAD.0b013e32835fab77.
Hutter G. Stem cell transplantation in strategies for curing HIV/AIDS. AIDS Res Ther. 2016 Sep 13;13(1):31. doi: 10.1186/s12981-016-0114-y. eCollection 2016.
Wang Fu-Sheng
Beijing 302 Hospital
First Submitted
September 8, 2015
First Posted
January 7, 2016
Study Start
October 2016
Actual (reported)Primary Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Corbeau P, Reynes J. Immune reconstitution under antiretroviral therapy: the new challenge in HIV-1 infection. Blood. 2011 May 26;117(21):5582-90. doi: 10.1182/blood-2010-12-322453. Epub 2011 Mar 14.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 19, 2019
Record last verified: 2019-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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