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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 weeks
Treatment ~ Varies
Follow Up ~96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

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

Find a Location

Who is running the clinical trial?

Saint Michael's Medical CenterLead Sponsor
5 Previous Clinical Trials
210 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
359 Previous Clinical Trials
468,503 Total Patients Enrolled
Jihad Slim, MDPrincipal InvestigatorSaint Michael's Medical Cettner
5 Previous Clinical Trials
134 Total Patients Enrolled

Media Library

Dolutegravir/Lamivudine (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT04826562 — Phase 4
HIV/AIDS Research Study Groups: dolutegravir/lamivudine
HIV/AIDS Clinical Trial 2023: Dolutegravir/Lamivudine Highlights & Side Effects. Trial Name: NCT04826562 — Phase 4
Dolutegravir/Lamivudine (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04826562 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the process of enrolling participants ongoing for this trial?

"As indicated on clinicaltrials.gov, this specific trial is no longer searching for participants as it was posted on September 26th 2021 and last updated May 3rd 2022. Nevertheless, over six hundred eighty five alternative medical studies are currently recruiting patients."

Answered by AI

What is the current enrollment for this experiment?

"This medical investigation is no longer searching for volunteers. The trial was first published on September 26th 2021 and amended May 3rd 2022. Alternatively, 636 HIV-related clinical trials are still recruiting patients while 49 studies focus specifically on Dolutegravir/Lamivudine therapies."

Answered by AI

What other research has been done to explore the efficacy of Dolutegravir/Lamivudine?

"Currently, there are 49 clinical trials investigating the effectiveness of Dolutegravir/Lamivudine. Of those studies, 17 progress to Phase 3 and involve 356 different medical centres worldwide--the majority being situated in Toronto, Ontario."

Answered by AI

Has the FDA endorsed Dolutegravir/Lamivudine for medicinal use?

"The safety of Dolutegravir/Lamivudine is assessed to be a 3, as this medication has already achieved approval in Phase 4 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
Jihad Slim, MD 2021. "Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04826562.
~11 spots leftby Apr 2025
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