Reconstitution of HIV-specific Immunity Against HIV

This study is currently recruiting participants.

See

Contacts and Locations

Verified May 2017 by Linghua LI, Guangzhou 8th People's Hospital

Sponsor:

Collaborator:

Sun Yat-sen University

Information provided by (Responsible Party):

Linghua LI, Guangzhou 8th People's Hospital

ClinicalTrials.gov Identifier:

NCT02563509

First received: September 13, 2015

Last updated: May 21, 2017

Last verified: May 2017

History of Changes

Purpose

Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so the viruses could not massively replicate when HAART was discontinued, then make HIV functional cure possible.

Condition	Intervention	Phase
HIV	Biological: HIV-specific CD8 cells	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Reconstitution of HIV-specific Immunity Against HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Linghua LI, Guangzhou 8th People's Hospital:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

All adverse events [ Time Frame: 6 Months ]
Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.


Estimated Enrollment:	40
Study Start Date:	January 2013
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).

Detailed Description:

The research aims at establishing a new treatment strategies of HIV. It will significantly improve the clinical therapy effects and effectively reduce the morbidity and mortality by reconstituting the immune systems of HIV infected patients and combining multiple therapy strategies. Therefore, the research could develop an cloning amplification system of immunocytes in vitro, and improve the antiviral immune system severely damaged before by transfusing the clone cells modified by specific HIV antigen. So HIV infected patients could discontinue the traditional anti-viral drug, but not develop opportunistic infections,which could obviously increase the life qualities of these patients.

Eligibility


Ages Eligible for Study:	16 Years to 60 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02563509

Contacts


Contact: LingHua LI, doctor	13725297174	llheliza@126.com

Locations


China, Guangdong
Guangzhou 8th People's Hospital	Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua LI, doctor 13725297174 llheliza@126.com

Sponsors and Collaborators

Guangzhou 8th People's Hospital

Sun Yat-sen University

Investigators


Principal Investigator:	Hui Zhang, doctor	Sun Yat-sen University

More Information

Publications:

Sandler NG, Bosinger SE, Estes JD, Zhu RT, Tharp GK, Boritz E, Levin D, Wijeyesinghe S, Makamdop KN, del Prete GQ, Hill BJ, Timmer JK, Reiss E, Yarden G, Darko S, Contijoch E, Todd JP, Silvestri G, Nason M, Norgren RB Jr, Keele BF, Rao S, Langer JA, Lifson JD, Schreiber G, Douek DC. Type I interferon responses in rhesus macaques prevent SIV infection and slow disease progression. Nature. 2014 Jul 31;511(7511):601-5. doi: 10.1038/nature13554. Epub 2014 Jul 9.

Bouchat S, Gatot JS, Kabeya K, Cardona C, Colin L, Herbein G, De Wit S, Clumeck N, Lambotte O, Rouzioux C, Rohr O, Van Lint C. Histone methyltransferase inhibitors induce HIV-1 recovery in resting CD4(+) T cells from HIV-1-infected HAART-treated patients. AIDS. 2012 Jul 31;26(12):1473-82. doi: 10.1097/QAD.0b013e32835535f5. Erratum in: AIDS. 2013 Jun 19;27(10):1683.

Crawford TQ, Hecht FM, Pilcher CD, Ndhlovu LC, Barbour JD. Activation associated ERK1/2 signaling impairments in CD8+ T cells co-localize with blunted polyclonal and HIV-1 specific effector functions in early untreated HIV-1 infection. PLoS One. 2013 Oct 15;8(10):e77412. doi: 10.1371/journal.pone.0077412. eCollection 2013.

Fidler S, Olson A, Fox J, Phillips A, Morrison C, Thornhill J, Bucher H, Muga R, Porter K. The importance of viral blips and duration of therapy initiated in primary infection in maintaining viral control after stopping cART. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19820. doi: 10.7448/IAS.17.4.19820. eCollection 2014.

Archin NM, Sung JM, Garrido C, Soriano-Sarabia N, Margolis DM. Eradicating HIV-1 infection: seeking to clear a persistent pathogen. Nat Rev Microbiol. 2014 Nov;12(11):750-64. doi: 10.1038/nrmicro3352. Review.

Chew N, Tan E, Li L, Lim R. HIV-1 tat and rev upregulates osteoclast bone resorption. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19724. doi: 10.7448/IAS.17.4.19724. eCollection 2014.

Abdel-Mohsen M, Deng X, Danesh A, Liegler T, Jacobs ES, Rauch A, Ledergerber B, Norris PJ, Günthard HF, Wong JK, Pillai SK. Role of microRNA modulation in the interferon-α/ribavirin suppression of HIV-1 in vivo. PLoS One. 2014 Oct 2;9(10):e109220. doi: 10.1371/journal.pone.0109220. eCollection 2014.

Vandergeeten C, Fromentin R, DaFonseca S, Lawani MB, Sereti I, Lederman MM, Ramgopal M, Routy JP, Sékaly RP, Chomont N. Interleukin-7 promotes HIV persistence during antiretroviral therapy. Blood. 2013 May 23;121(21):4321-9. doi: 10.1182/blood-2012-11-465625. Epub 2013 Apr 15.

Cahn P, Ruxrungtham K, Gazzard B, Diaz RS, Gori A, Kotler DP, Vriesema A, Georgiou NA, Garssen J, Clerici M, Lange JM; (BTE) Blinded Nutritional Study for Immunity and Tolerance Evaluation Study Team. The immunomodulatory nutritional intervention NR100157 reduced CD4+ T-cell decline and immune activation: a 1-year multicenter randomized controlled double-blind trial in HIV-infected persons not receiving antiretroviral therapy (The BITE Study). Clin Infect Dis. 2013 Jul;57(1):139-46. doi: 10.1093/cid/cit171. Epub 2013 Mar 19.


Responsible Party:	Linghua LI, Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier:	NCT02563509 History of Changes
Other Study ID Numbers:	2013ZX10001004
Study First Received:	September 13, 2015
Last Updated:	May 21, 2017
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

Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:


HIV cellular immunity therapy functional cure

ClinicalTrials.gov processed this record on July 17, 2017

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