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Antiretroviral
DOVATO Switch for HIV/AIDS Management (Sound Trial)
Phase 4
Waitlist Available
Led By Jihad Slim, MD
Research Sponsored by Saint Michael's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks
Awards & highlights
Sound Trial Summary
This trial is testing whether it's safe to switch HIV patients who are already taking Bitarvy and are virologically suppressed to Dovato.
Who is the study for?
This trial is for adults over 18 with HIV who are currently on Biktarvy and have maintained a viral load under 50 copies/mL for at least six months. They must not have had virologic failure while on an integrase inhibitor, no severe liver issues or hepatitis B, and agree to use effective contraception if of child-bearing potential.Check my eligibility
What is being tested?
The SOUND study is testing the switch from Biktarvy to Dovato (Dolutegravir/Lamivudine) in patients whose HIV is already well-controlled. It's an open-label pilot study which means everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects of Dovato may include headache, diarrhea, nausea, fatigue, insomnia, and allergic reactions. Since it's a combination drug containing dolutegravir and lamivudine, side effects associated with these individual drugs could also occur.
Sound Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Virologic Failure
Secondary outcome measures
Retrospective Baseline Resistance
Virologic Suprresion
Sound Trial Design
1Treatment groups
Experimental Treatment
Group I: dolutegravir/lamivudineExperimental Treatment1 Intervention
dolutegravir/lamivudine
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for HIV/AIDS, such as the combination of Dolutegravir and Lamivudine found in Dovato, work by targeting essential enzymes required for viral replication. Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks the HIV integrase enzyme, preventing the integration of viral DNA into the host cell genome.
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that inhibits the reverse transcriptase enzyme, which is crucial for converting viral RNA into DNA. By inhibiting these enzymes, these drugs effectively reduce viral replication and maintain low viral loads, which is critical for improving immune function and reducing the risk of HIV-related complications in patients.
HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review.[Novelties in HIV prevention and treatment in 2019].Dolutegravir maintains a durable effect against HIV replication in tissue culture even after drug washout.
HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review.[Novelties in HIV prevention and treatment in 2019].Dolutegravir maintains a durable effect against HIV replication in tissue culture even after drug washout.
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Who is running the clinical trial?
Saint Michael's Medical CenterLead Sponsor
5 Previous Clinical Trials
210 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
361 Previous Clinical Trials
468,607 Total Patients Enrolled
Jihad Slim, MDPrincipal InvestigatorSaint Michael's Medical Cettner
5 Previous Clinical Trials
134 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have liver disease that is not stable or cirrhosis, or you have known issues with your bile ducts (except for harmless conditions like Gilbert's syndrome or asymptomatic gallstones).You are allergic to dolutegravir or lamivudine.
Research Study Groups:
This trial has the following groups:- Group 1: dolutegravir/lamivudine
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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