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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02231281
Other study ID # 2014ZX10001002-001
Secondary ID 2014ZX10001002-0
Status Active, not recruiting
Phase Phase 3
First received August 26, 2014
Last updated April 24, 2018
Start date August 2014
Est. completion date December 2018

Study information

Verified date April 2018
Source Tang-Du Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the ability of the early initiation of cART or cART in combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to achieve a post-treatment control among treatment-naïve acute HIV-infected adults.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
cART(TDF/AZT+3TC+LPV/r)
Standard antiretroviral therapy for HIV infection
Procedure:
CTL infusion
cART(TDF/AZT+3TC+LPV/r) plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion

Locations

Country Name City State
China Beijing You'an Hospital, Capital Medical University Beijing Beijing
China National Center for STD and AIDS Control and Prevention, Chinese Center for Disease Control and Prevention Beijing Beijing
China Zhejiang University Hangzhou Zhejiang
China Shandong Center for Disease Control and Prevention Jinan Shandong
China The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
China China Medical University Shenyang Liaoning
China Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical Universit Xi'an Shaanxi

Sponsors (8)

Lead Sponsor Collaborator
Yongtao Sun, MD, PhD Beijing YouAn Hospital, China Medical University, China, First Affiliated Hospital of Guangxi Medical University, National Center for AIDS/STD Control and Prevention, China CDC, Shandong Province Centers for Disease Control and Prevention, Tang-Du Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in HIV DNA quantification at the interruption of cART HIV DNA detection includes total HIV DNA, integrated HIV DNA , 2-long terminal repeat (LTR) HIV DNA in resting CD4+T cell subsets. 48 weeks for Cohort 1, 72 weeks for Cohort 2, 96 weeks for Cohort 3
Primary Number of patients who achieve virological remission Virological remission is defined as undetectable of plasma HIV RNA for 24 weeks after the interruption of cART. 72 weeks for Cohort 1, 96 weeks for Cohort 2, 120 weeks for Cohort 3
Secondary Number of patients who occur any grade 3 or 4 (clinical or laboratory) adverse events 120 weeks
Secondary Number of patients who need to initiate late treatment Late treatment is defined cART should be administered according to local HIV treatment guidelines. 120 weeks
Secondary Time from cART interruption to virological relapse (plasma viral load more than 50 copies/mL) 120 weeks
Secondary HIV-1 specific CD4+ and CD8+ T cell responses at week 120 120 weeks
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