Reconstitution of HIV-specific Immunity Against HIV

HIV Clinical Trial

Official title:

Reconstitution of HIV-specific Immunity Against HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563509
• Other study ID #: 2013ZX10001004
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2019
• Source: Guangzhou 8th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

1. HIV infection confirmed

2. Receiving HAART more than 6 months

3. HIV viral-load < 50 copies/ml

4. Without serious damage of liver and kidney

5. The subject volunteered to the research and sign the informed consent

Exclusion Criteria:

1. With serious opportunistic infections

2. With serious chronic disease such like diabetes, the mental illness,et al

3. History of suffering from pancreatitis during HAART.

4. Pregnant and breast-fed.

5. With poor adherence

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• HIV-specific CD8 cells
Based on HAART, receive HIV-specific CD8 cells transfuion.

Locations

Country	Name	City	State
China	Guangzhou 8th People's Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou 8th People's Hospital	Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (9)

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-a/ribavirin suppression of HIV-1 in vivo. PLoS One. 2014 Oct 2;9(10):e109220. doi: 10.1371/journal.pone.0109220. eCollection 2014. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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, Lifso — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and function of HIV-specific CD8 cells in patients with HIV	The change of differentiation, proliferation, apoptosis, phenotype, etal.	6 Months
Secondary	All adverse events	Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.	6 Months