What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS, particularly those involving Dolutegravir and Lamivudine, are generally well-tolerated. Dolutegravir can cause dizziness and sleep disturbances, while Lamivudine may lead to mild headaches and gastrointestinal issues. Both drugs have minimal impact on renal function, lipid profiles, and bone mineral density. Resistance to integrase strand transfer inhibitors is rare but has been observed in complex treatment-experienced individuals.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of HIV/AIDS that are similar to Dovato, which combines Dolutegravir and Lamivudine. Dolutegravir is an integrase inhibitor, and other FDA-approved integrase inhibitors include Raltegravir and Elvitegravir. Lamivudine is a reverse transcriptase inhibitor, and other drugs in this class include Zidovudine, Emtricitabine, and Tenofovir. These medications work by inhibiting key enzymes necessary for HIV replication, thereby reducing viral load and improving immune function in patients.

What other types of research exist?

Promising alternatives to Dovato for HIV/AIDS treatment in 2024 include Biktarvy (Bictegravir/Emtricitabine/Tenofovir alafenamide), which combines an integrase inhibitor with two nucleoside reverse transcriptase inhibitors (NRTIs) and has shown high efficacy and a favorable safety profile. Another option is Cabenuva (Cabotegravir/Rilpivirine), a long-acting injectable regimen that offers the convenience of monthly or bimonthly dosing. Additionally, Lenacapavir, a novel capsid inhibitor currently in clinical trials, shows potential as a long-acting treatment option.

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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing what happens when patients with well-controlled HIV switch from one medication to another. The study focuses on people whose HIV levels are already very low. Both medications work by stopping the virus from making more copies of itself.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Virologic Failure

Secondary study objectives

Retrospective Baseline Resistance

Virologic Suprresion

Awards & Highlights

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: dolutegravir/lamivudineExperimental Treatment1 Intervention

dolutegravir/lamivudine

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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.