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HIVPhase 1NCT02563509

Reconstitution of HIV-specific Immunity Against HIV

A Phase 1 study testing HIV-specific CD8 cells in people with HIV, run by Guangzhou 8th People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
HIV
What is being tested?
HIV-specific CD8 cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangzhou 8th People's Hospital

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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.

Read the 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.

Conditions
HIV
Being tested
HIV-specific CD8 cells
Keywords
HIV, cellular immunity therapy, functional cure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV-specific CD8 cellsBiological

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

Study groups in NCT02563509
Study groupRoleWhat they receive
HIV-specific CD8 cellsExperimentalTransfusing HIV-specific CD8 cells 50-100mlonce a week for four times.
Receives: Biological: HIV-specific CD8 cells
Regualar therapyNo interventionOnly receiving Highly active anti-retroviral therapy(HAART).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 Months

Secondary outcomes (1)

  1. All adverse events

    Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563509
Sponsor's protocol ID
2013ZX10001004
Status last verified
Jun 2019
First submitted
13 Sep 2015
Last updated
6 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25397564

  • 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.

    PubMed 25402363

  • 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.

    PubMed 25397470

  • 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.

    PubMed 25275557

  • 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.

    PubMed 23589672

  • 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.

    PubMed 23511299

  • 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.

    PubMed 25043006

  • 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.

    PubMed 22555163

  • 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.

    PubMed 24143233

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HIV-specific CD8 cells in people with HIV, run by Guangzhou 8th People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and function of HIV-specific CD8 cells in patients with HIV (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02563509, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.

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