HIV-1-infectionNCT05418790
Alternative Viral Load Tests During Start of Antiretroviral Therapy
A study testing TASSO device in people with HIV-1-infection, run by Luis Montaner.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- TASSO device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons living with HIV starting an ART regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/mL
Who cannot join
- Persons living with HIV suppressed on ART regimen.
About this study
Official title: A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy in Persons Living With HIV: Reliability and Acceptability of Home Test Measures
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.
Read the detailed description
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.
There are three planned research viral load evaluations in the trial, which may include but are not limited to the evaluations listed below:
- CLINICAL CARE VIRAL LOAD - This will take place at the clinic during the regular clinical follow-up to confirm effective viral suppression.. During these visits an HIV viral load sample will be collected using traditional venipuncture methods and analyzed using a qualified commercial test. These plasma values may be used as a comparator with other viral load test results.
- CLINIC TASSO COLLECTION - Participants will collect one or more Tasso device specimen(s) during in-clinic study visits. The main objective of these measurements is to evaluate HIV viral load monitoring using novel collection approaches with the supervision of trained study staff to minimize user error potential.
- HOME TASSO COLLECTION - Participants will be provided with Tasso devices to use at home in between regular parent study visits. These devices will be shipped in real-time to Wistar Institute for archiving before HIV viral loads will be measured. The main objective of these measurements is to evaluate the feasibility HIV viral load monitoring using novel collection approaches at home.
- Conditions
- HIV-1-infection
- Being tested
- TASSO device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASSO deviceDevice
During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home.
| Study group | Role | What they receive |
|---|---|---|
| TASSO device | Experimental | During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home. Receives: Device: TASSO device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jun 2022
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Why it stopped: Not pursued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Montaner
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Luis Montaner, The Wistar Institute
- Investigators
- Luis Montaner, Principal investigator, The Wistar Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418790
- Sponsor's protocol ID
- TASSO starting ART
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy in Persons Living With HIV: Reliability and Acceptability of Home Test Measures
- ClinicalTrials.gov ID
- NCT05418790
- Acronym / sponsor ID
- TASSO starting ART
- Conditions
- HIV-1-infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not pursued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Luis MontanerUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
There are three planned research viral load evaluations in the trial, which may include but are not limited to the evaluations listed below:
- CLINICAL CARE VIRAL LOAD - This will take place at the clinic during the regular clinical follow-up to confirm effective viral suppression.. During these visits an HIV viral load sample will be collected using traditional venipuncture methods and analyzed using a qualified commercial test. These plasma values may be used as a comparator with other viral load test results.
- CLINIC TASSO COLLECTION - Participants will collect one or more Tasso device specimen(s) during in-clinic study visits. The main objective of these measurements is to evaluate HIV viral load monitoring using novel collection approaches with the supervision of trained study staff to minimize user error potential.
- HOME TASSO COLLECTION - Participants will be provided with Tasso devices to use at home in between regular parent study visits. These devices will be shipped in real-time to Wistar Institute for archiving before HIV viral loads will be measured. The main objective of these measurements is to evaluate the feasibility HIV viral load monitoring using novel collection approaches at home.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TASSO device | Experimental | Device: TASSO deviceDuring this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons living with HIV starting an ART regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/mL
Key exclusion criteria (1 listed)
- Persons living with HIV suppressed on ART regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TASSO deviceDuring this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home. | Device | TASSO device |
Primary outcome
Accuracy of Tasso viral load test
Time frame: 12 months
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.
Questionnaire to assess feasibility of implementing a home-based viral load test
Time frame: 12 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Montaner principal investigator
The Wistar Institute
Questions about this trial
What is this clinical trial studying?
A study testing TASSO device in people with HIV-1-infection, run by Luis Montaner.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Tasso viral load test (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.