Alternative Viral Load Tests During Start of Antiretroviral Therapy

NCT05418790 | Withdrawn

• 1 other identifier: TASSO starting ART
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in HIV care. Approximately 15 participants starting ART, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• Accuracy of Tasso viral load test

  Determine the accuracy of Tasso viral load tests to detect changes in viral load in participants starting ART or reflect resuppression kinetics from a detectable viral load ≥ 5,000 copies/mL at last measurement when compared to standard clinical CLIA certified viral load measures.

  12 months

• Questionnaire to assess feasibility of implementing a home-based viral load test

  Administer questionnaire to determine the feasibility of implementing a home-based viral load test in the context of starting ART or working to resuppress a detectable viral load ≥5,000 copies/mL at last measurement.

  12 months

Study Arms (1)

TASSO device

EXPERIMENTAL

During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home.

Device: TASSO device

Interventions

TASSO device DEVICE

During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home.

TASSO device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons living with HIV starting an ART regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/mL

You may not qualify if:

• Persons living with HIV suppressed on ART regimen.

Sponsors & Collaborators

• Luis Montaner: lead
• Merck Sharp & Dohme LLC: collaborator

Study Officials

• Luis Montaner

  The Wistar Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: June 1, 2022
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: June 3, 2026

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share