Reconstitution of HIV-specific Immunity Against HIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02563509|
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : June 6, 2019
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|Condition or disease||Intervention/treatment||Phase|
|HIV||Biological: HIV-specific CD8 cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reconstitution of HIV-specific Immunity Against HIV|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||December 2017|
Experimental: HIV-specific CD8 cells
Transfusing HIV-specific CD8 cells 50-100mlonce a week for four times.
Biological: HIV-specific CD8 cells
Based on HAART, receive HIV-specific CD8 cells transfuion.
No Intervention: Regualar therapy
Only receiving Highly active anti-retroviral therapy(HAART).
- The number and function of HIV-specific CD8 cells in patients with HIV [ Time Frame: 6 Months ]The change of differentiation, proliferation, apoptosis, phenotype, etal.
- All adverse events [ Time Frame: 6 Months ]Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.
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|Ages Eligible for Study:||16 Years to 60 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- HIV infection confirmed
- Receiving HAART more than 6 months
- HIV viral-load < 50 copies/ml
- Without serious damage of liver and kidney
- The subject volunteered to the research and sign the informed consent
- With serious opportunistic infections
- With serious chronic disease such like diabetes, the mental illness,et al
- History of suffering from pancreatitis during HAART.
- Pregnant and breast-fed.
- With poor adherence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563509
|Guangzhou 8th People's Hospital|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Hui Zhang, doctor||Sun Yat-sen University|
|Responsible Party:||Linghua LI, Chief physician, Guangzhou 8th People's Hospital|
|Other Study ID Numbers:||
|First Posted:||September 30, 2015 Key Record Dates|
|Last Update Posted:||June 6, 2019|
|Last Verified:||June 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
cellular immunity therapy