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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 : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date August 20, 2019
First Posted Date August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date January 28, 2017
Actual Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement for Viral Reservoir and Immune Function in HIV-1-infected Patients Under Antiretroviral Therapy
Official Title Measurement for Viral Reservoir and Immune Function in HIV-1-infected Patients Under Antiretroviral Therapy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HIV-1 infected patients receiving antiretroviral treatment
Condition HIV-1-infection
Intervention Other: no intervention
No intervention
Study Groups/Cohorts
  • Regular treatment
    Intervention: Other: no intervention
  • Treatment interruption
    Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 20, 2019
Actual Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: SZU-MIN Hsieh, M.D. 886-2-23123456 ext 67736 hsmaids@hotmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04068441
Other Study ID Numbers 201904090RINA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Szu-Min Hsieh, M.D. National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date August 2019