DOVATO for HIV

Overseen By Jones Kalyniuk, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Saskatchewan Health Authority - Regina Area

Must be taking: Opioid agonist therapy

Must not be taking: Hepatitis B drugs

Disqualifiers: Hepatitis B, Tuberculosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if individuals living with HIV on opioid treatment (such as methadone or buprenorphine) can maintain their health when switching their HIV medication to Dovato, a combination of dolutegravir and lamivudine. The study will assess whether the switch effectively controls the virus and will monitor any side effects or changes in opioid treatment. Additionally, it will evaluate participants' satisfaction with their new medication. The trial seeks participants who have been on stable opioid treatment and have successfully managed their HIV with their current medications. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial requires participants to switch from their current HIV medications to Dovato (DTG/3TC). However, it does not specify if you need to stop other medications, so it's best to discuss this with the study team.

What is the safety track record for Dovato?

Research has shown that Dolutegravir/Lamivudine (Dovato) is generally well-tolerated by people with HIV. In several studies, Dovato demonstrated safety results similar to the usual three-drug treatments, indicating that users often experience as few side effects as those on standard treatments.

For instance, one study found that after 48 weeks, Dovato was as effective and safe as a three-drug regimen. Another analysis revealed that people starting Dovato had similar safety outcomes, regardless of their initial viral load.

Moreover, long-term data from ViiV Healthcare supports Dovato's safety, showing that it remains safe and effective over several years. While some individuals might experience minor side effects, serious issues are rare.

Overall, the FDA has approved Dovato, confirming it has passed strict safety tests for treating HIV. This approval provides additional confidence in its safety for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

DOVATO is unique because it combines two active ingredients, dolutegravir and lamivudine, into a single pill, simplifying HIV treatment regimens. Unlike the standard of care, which often involves multiple medications like tenofovir and emtricitabine, DOVATO offers a two-drug regimen that is effective for maintaining viral suppression. Researchers are excited about this treatment because it has the potential to reduce the pill burden for patients, improve adherence, and minimize long-term side effects associated with more complex antiretroviral therapies.

What is the effectiveness track record for Dovato in maintaining viral suppression in people with HIV-1 on opioid agonist therapy?

Research has shown that Dovato, a combination of Dolutegravir and Lamivudine (DTG/3TC), effectively controls the HIV virus. One study found that 91.9% of participants maintained viral control after switching to Dovato, with only 11.1% experiencing serious side effects. Another study revealed that after 48 weeks, 82% of those using Dovato had very low virus levels, comparable to those taking three drugs. Additionally, the long-term failure rate for this treatment is less than 6% over three years in real-world use. This evidence supports Dovato's effectiveness for individuals who already have the virus under control. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for HIV-positive individuals who are currently on a stable antiretroviral therapy and also receiving opioid agonist therapy. They must have maintained viral suppression (HIV-1 RNA < 200 copies/mL). Participants should not be planning to change their opioid treatment and must consent to regular blood draws, questionnaires, ECGs, urine screenings, and reviews of medication.

Inclusion Criteria

Ability to remain adherent to medications and study protocol as per investigator opinion

HIV-1 infected

I have been on HIV medication, but not specifically Dolutegravir/Lamivudine together.

Exclusion Criteria

History or presence of allergy to any component of DTG/3TC

I am positive for hepatitis B.

I am currently being treated for tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants switch to Dolutegravir/Lamivudine (DTG/3TC) from their current suppressive ART and are monitored for viral suppression and adverse events

48 weeks

Regular visits (in-person) for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of viral suppression and adverse events

4 weeks

2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to further assess safety and efficacy

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Dolutegravir/Lamivudine (DTG/3TC)

Trial Overview

The study tests if switching HIV patients on opioid agonist therapy from their current ART to Dolutegravir/Lamivudine (DTG/3TC or 'Dovato') keeps the virus suppressed after 48 weeks. It will monitor adverse events related to DTG/3TC, changes in OAT dosing due to DTG/3TC, substance use impact on viral suppression, kidney function changes, lipid levels shifts, patient satisfaction with treatment and symptoms of opioid withdrawal or overdose.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Switch to Dolutegravir/Lamivudine ("DOVATO") from current suppressive antiretroviral therapy in people living with HIV-1 receiving opioid agonist therapy.

Who Is Running the Clinical Trial?

Saskatchewan Health Authority - Regina Area

Lead Sponsor

Trials

29

Recruited

5,400+

ViiV Healthcare

Industry Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Published Research Related to This Trial

In a study involving 10,043 treatment-naive patients with HIV-1, the 2-drug regimen of dolutegravir and lamivudine (DTG+3TC) showed similar efficacy in achieving viral suppression at 48 weeks compared to traditional 3-drug regimens, with significant superiority over efavirenz-based treatments.

Safety outcomes, including adverse events and CD4 cell count changes, were broadly similar between DTG+3TC and the other regimens, indicating that DTG+3TC is a safe and effective alternative to more complex treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety and dolutegravir and lamivudine in treatment naive HIV patients. Radford, M., Parks, DC., Ferrante, S., et al.[2020]

Citations

1.

viivhealthcare.com

viivhealthcare.com/en-us/media-center/news/press-releases/2025/october/viiv-healthcare-announces-96-week-data/

ViiV Healthcare announces 96-week data reaffirming ...

Results at 96 weeks showed patients who switched to Dovato achieved non-inferior efficacy in maintaining viral suppression compared with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12366928/

Dolutegravir + lamivudine effectiveness and tolerability in ...

Dolutegravir (DTG) + lamivudine (3TC) has demonstrated efficacy and safety in phase 3 clinical trials; however, most published data are from ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40874763/

48-Week Results of the DOLCE Study

Per-protocol analysis showed a response rate of 91.9%. Severe adverse events (n = 17) were reported in 15 of 152 participants (11.1%).

4.

academic.oup.com

academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf345/8262028

Effectiveness of first-line lamivudine/dolutegravir antiretroviral ...

In our real-world setting, the TF probability for first-line lamivudine/dolutegravir was below 6% at 3 years, lower than in randomized trials.

5.

viivhealthcare.com

viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/november/dovato-is-highly-effective-in-treatment-naive-people/

Data presented at HIV Glasgow from the DOLCE study ...

At week 48 comparable efficacy was observed, with 82% of individuals in the DTG/3TC group and 80% in the 3-drug regimen group achieving a VL<50.

6.

academic.oup.com

academic.oup.com/ofid/article/12/3/ofaf135/8059175

Efficacy and Safety Outcomes in Adults Initiating Dolutegravir ...

This post hoc analysis evaluated dolutegravir/lamivudine efficacy and safety by baseline viral load (VL) categories in participants naive to antiretroviral.

7.

viivhealthcare.com

viivhealthcare.com/en-us/media-center/news/press-releases/2020/september/viiv-healthcare-to-present-long-term-safety-and-efficacy-data-fo/

ViiV Healthcare to present long-term safety and efficacy ...

These three-year data will build upon 96-week results, which demonstrated the non-inferior efficacy of dolutegravir plus lamivudine compared to the 3-drug ...