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Measurement for Viral Reservoir and Immune Function in HIV-1-infected Patients Under Antiretroviral Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068441
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
Current antiretroviral therapy (ART) is highly effective to suppress plasma viral load to below the detection limit and to restore the host immunity, thus to prolong the survival of HIV-1-infected patients remarkably. However, HIV-1 will rebound to pre-treatment levels within weeks of interruption or irregular medication. The reason why HIV-1 would not be eradicated by powerful ART can be explained by that the reservoir of latent HIV-1 in resting CD4 T cells will persistently exist even long-term suppression of plasma viral RNA. Several therapeutic approaches that aim to prevent or delay viral rebound after treatment interruption, producing a post-treatment remission or functional cure of HIV-1, are being investigated. This study is to measure the size of viral reservoir and HIV-1-specific T cell response in HIV-1-infected patients during ART to help understand the mechanism of HIV-1 persistence, then to help establish a potential policy for functional cure.

Condition or disease Intervention/treatment
HIV-1-infection Other: no intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement for Viral Reservoir and Immune Function in HIV-1-infected Patients Under Antiretroviral Therapy
Actual Study Start Date : January 28, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
Regular treatment Other: no intervention
No intervention
Treatment interruption Other: no intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Changes of Proviral DNA levels [ Time Frame: The changes of baseline proviral DNA at 48 weeks ]
    quantitative proviral DNA measurement as the marker of HIV reservoir


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1 infected patients receiving antiretroviral treatment
Criteria

Inclusion Criteria:

  • Confirmed HIV-1-infected patients
  • 20-50 years old
  • receiving antiretroviral therapy

Exclusion Criteria:

  • Serious co-morbidity
  • Obvious hepatic or renal dysfunction
  • Receiving immunosuppressive therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068441


Contacts
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Contact: SZU-MIN Hsieh, M.D. 886-2-23123456 ext 67736 hsmaids@hotmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Szu-Min Hsieh, M.D.    886223123456 ext 67736    hsmaids@hotmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Szu-Min Hsieh, M.D. National Taiwan University Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04068441    
Other Study ID Numbers: 201904090RINA
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No