Human Immunodeficiency VirusPhase 4SoundNCT04826562
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
A Phase 4 study testing Dolutegravir/Lamivudine in people with Human Immunodeficiency Virus, run by Saint Michael's Medical Center at 1 site in United States.
Trial summary
An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Dolutegravir/Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2021to 30 Dec 2023
- Phase
- Phase 4
- 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
- Confirmed HIV-1 infection
- Age of 18 years or older
- On Biktarvy for at >24 weeks with HIV viral load < 50 copies /mL for > 6 months immediately prior to enrollment
- Agree to consistently use an effective method of contraception (see Appendix: Highly Effective Methods for Avoiding Pregnancies in Females of Reproductive Potential) for women of child-bearing potential
- Willingness to sign the informed consent
- If history of virologic failure must be fully suppressed (HIV-1 RNA<50 copies/mL) for at least 12 months before screening visit
- No prior HIV genotype or phenotype available
Who cannot join
- Hypersensitivity to dolutegravir and/or lamivudine
- History of virologic failure while on an integrase inhibitor
- Taking any medication contraindicated for co-administration with dolutegravir and/or lamivudine according to manufacturer's current medication package inserts
- HIV-1 RNA ≥50 copies/mL (confirmed) in the past 48 weeks after initial suppression on therapy to HIV-1 RNA <50 copies/mL
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
- Participants positive for HBsAg are excluded.
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- Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
- Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. Anti-HBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM. Participants with a documented history of chronic HBV and current undetectable HBV DNA while on a Biktarvy are excluded.
- Pregnant women, women actively seeking to become pregnant, and women of child-bearing potential who are not using effective contraception
- Severe hepatic impairment (Child-Pugh C)
- Critically ill and/or unable to take oral medications
- Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe for the subject
- Creatinine clearance < 30 mL/min/1.73m2 via CKD-EPI method
- ALT > 5x the upper limit of normal (ULN) or ALT > 3x ULN and total bilbirubin >1.5x ULN (and >35% directed bilirubin)
- Subjects with an anticipated need for hepatitis C virus therapy with interferon and/or ribavirin prior to the primary endpoint
- Unstable liver disease, cirrhosis, and/or known biliary abnormalities (except for hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Michael's Medical Center
Newark, New Jersey, 07102
About this study
An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Dolutegravir/Lamivudine
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir/LamivudineDrug
Also called Dovato
single tablet antiretroviral
| Study group | Role | What they receive |
|---|---|---|
| dolutegravir/lamivudine | Experimental | dolutegravir/lamivudine Receives: Drug: Dolutegravir/Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Failure
To determine the % of virologic failures (VL ≥ 50 copies/mL at week 48 using the FDA ITT, Snapshot analysis
Measured: 48 weeks
Secondary outcomes (2)
Virologic Suprresion
To determine the % of subjects remaining virologically suppressed at weeks 48 and 96 using the Snapshot algorithm
Measured: 96 weeks
Retrospective Baseline Resistance
to determine the percentage baseline resistance after 96 weeks of treatment
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start26 Sep 2021
- Primary completion6 Oct 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Michael's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Jihad Slim, MD, Saint Michael's Medical Center
- Investigators
- Jihad Slim, MD, Principal investigator, Saint Michael's Medical Cettner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826562
- Sponsor's protocol ID
- 09/21
- Acronym
- Sound
- Status last verified
- Oct 2023
- First submitted
- 28 Mar 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
- ClinicalTrials.gov ID
- NCT04826562
- Acronym / sponsor ID
- Sound / 09/21
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saint Michael's Medical CenterUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Apr 2021 (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.
An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dolutegravir/lamivudine | Experimental | Drug: Dolutegravir/Lamivudinedolutegravir/lamivudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed HIV-1 infection
- Age of 18 years or older
- On Biktarvy for at >24 weeks with HIV viral load < 50 copies /mL for > 6 months immediately prior to enrollment
- Agree to consistently use an effective method of contraception (see Appendix: Highly Effective Methods for Avoiding Pregnancies in Females of Reproductive Potential) for women of child-bearing potential
- Willingness to sign the informed consent
Key exclusion criteria (16 listed)
- Hypersensitivity to dolutegravir and/or lamivudine
- History of virologic failure while on an integrase inhibitor
- Taking any medication contraindicated for co-administration with dolutegravir and/or lamivudine according to manufacturer's current medication package inserts
- HIV-1 RNA ≥50 copies/mL (confirmed) in the past 48 weeks after initial suppression on therapy to HIV-1 RNA <50 copies/mL
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
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 |
|---|---|---|
| Dolutegravir/LamivudineAlso: Dovatosingle tablet antiretroviral | Drug | dolutegravir/lamivudine |
Primary outcome
Virologic Failure
Time frame: 48 weeks
To determine the % of virologic failures (VL ≥ 50 copies/mL at week 48 using the FDA ITT, Snapshot analysis
2 secondary outcomes
Virologic Suprresion
Time frame: 96 weeks
Retrospective Baseline Resistance
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- 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.
Jihad Slim, MD principal investigator
Saint Michael's Medical Cettner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir/Lamivudine in people with Human Immunodeficiency Virus, run by Saint Michael's Medical Center at 1 site in United States.
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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Virologic Failure (time frame: 48 weeks). 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 11 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.