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

NCT04068441 | Completed

• 1 other identifier: 201904090RINA
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Changes of Proviral DNA levels

  quantitative proviral DNA measurement as the marker of HIV reservoir

  The changes of baseline proviral DNA at 48 weeks

Study Arms (2)

Regular treatment

no intervention

Other: no intervention

Treatment interruption

no intervention

Other: no intervention

Interventions

no intervention OTHER

No intervention

Regular treatment; Treatment interruption

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1 infected patients receiving antiretroviral treatment

You may qualify if:

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

You may not qualify if:

• Serious co-morbidity
• Obvious hepatic or renal dysfunction
• Receiving immunosuppressive therapy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Hsieh SM, Pan SC, Huang YS, Chang SC. Reversal of Viral Latency and Induction of Gag-Specific T-Cell Responses in HIV-1-Infected Adults Through Cyclic Treatment Interruption of Rosuvastatin: A Proof-of-Concept Study. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):500-508. doi: 10.1097/QAI.0000000000002577.

  PMID: 33620177 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

sample with DNA

Study Officials

• Szu-Min Hsieh, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: January 28, 2017
• Primary Completion: January 21, 2021
• Study Completion: September 5, 2022
• Last Updated: October 17, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)