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Completed

NCT Number: NCT02563509

Reconstitution of HIV-specific Immunity Against HIV

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.

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Key information

Conditions

HIV

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangzhou 8th People's Hospital

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIV-specific CD8 cells

Biological

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

Primary outcomes

  1. 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 outcomes

  1. All adverse events

    Time frame: 6 Months

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

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Collaborators

  • Sun Yat-sen University

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2015
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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