DOVATO for HIV
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.12345Why 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.13467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants switch to Dolutegravir/Lamivudine (DTG/3TC) from their current suppressive ART and are monitored for viral suppression and adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of viral suppression and adverse events
Open-label extension (optional)
Participants may opt into continuation of treatment long-term to further assess safety and efficacy
What Are the Treatments Tested in This Trial?
Interventions
- Dolutegravir/Lamivudine (DTG/3TC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Saskatchewan Health Authority - Regina Area
Lead Sponsor
ViiV Healthcare
Industry Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration