NCT02563509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 hiv

Timeline
Completed

Started Jan 2016

Typical duration for phase_1 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

September 13, 2015

Last Update Submit

June 5, 2019

Conditions

HIV

Keywords

HIVcellular immunity therapyfunctional cure

Outcome Measures

Primary Outcomes (1)

  • The number and function of HIV-specific CD8 cells in patients with HIV

    The change of differentiation, proliferation, apoptosis, phenotype, etal.

    6 Months

Secondary Outcomes (1)

  • All adverse events

    6 Months

Study Arms (2)

HIV-specific CD8 cells

EXPERIMENTAL

Transfusing HIV-specific CD8 cells 50-100mlonce a week for four times.

Biological: HIV-specific CD8 cells

Regualar therapy

NO INTERVENTION

Only receiving Highly active anti-retroviral therapy(HAART).

Interventions

HIV-specific CD8 cellsBIOLOGICAL

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

HIV-specific CD8 cells

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou 8th People's Hospital

Guangzhou, Guangdong, 510060, China

Location

Related Publications (9)

  • 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.

    PMID: 25397564BACKGROUND

  • 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.

    PMID: 25402363BACKGROUND

  • 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.

    PMID: 25397470BACKGROUND

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

    PMID: 25275557BACKGROUND

  • Vandergeeten C, Fromentin R, DaFonseca S, Lawani MB, Sereti I, Lederman MM, Ramgopal M, Routy JP, Sekaly 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.

    PMID: 23589672BACKGROUND

  • 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.

    PMID: 23511299BACKGROUND

  • 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.

    PMID: 25043006RESULT

  • 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.

    PMID: 22555163RESULT

  • 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.

    PMID: 24143233RESULT

Study Officials

  • Hui Zhang, doctor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 30, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

June 6, 2019

Record last verified: 2019-06

Locations

CN(1)