AccessHealth MA is concerned about the increasing number of Monkeypox virus (MPV) cases in MA and the stigma surrounding it. Get the facts! We urge you to learn the symptoms of MPV and how to protect yourself.

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AccessHealth MA is concerned about the increasing number of Monkeypox virus (MPV) cases in MA and the stigma surrounding it. Get the facts! We urge you to learn the symptoms of MPV and how to protect yourself.

Learn More

Define Clinical Trial

Trial Nickname: Define

Name: D/C/F/TAF FDC Evaluated as a Fixed Dose Combination Regimen in Participants Switching from an Integrase Inhibitor who have Experienced Rapid Weight Gain.

Participant Overview: Community Research Initiative is recruiting participants for a paid research study to evaluate the safety and tolerability of switching to a once-daily Fixed-Dose Combination regimen for those experiencing weight gain on an Integrase Inhibitor + TAF/FTC ARV regimen.

Major Eligibility Criteria:
◊At least 18 years old
◊Have had a suppressed viral load
◊Have been on a stable Integrase Inhibitor + TAF/FTC ARV regimen for at least 6 months
◊Have a proven weight gain of least 10% of your body weight

Description: This is a randomized, 48 week, active-controlled, open-label, prospective, multicenter, Phase 4 study to evaluate the safety and tolerability of switching to D/C/F/TAF FDC compared to continuing the current INI + TAF/FTC ARV regimen in virologically-suppressed HIV-1 infected adult participants who have experienced rapid and significant body weight gain while receiving an INI + TAF/FTC ARV regimen. The HCV study treatment and all study-required labs and exams are provided at no cost. The HCV study treatment is a 12-week, fixed-dose course of once-daily sofosbuvir/velpatasivir. The study will consist of 3 phases: Screening (approximately 30 days [up to a maximum of 6 weeks]), Study Treatment Period (48 weeks), and Follow-up (for any participant who has an ongoing adverse event (AE) or serious adverse event (SAE) at the time of his/her last study visit).

Study Sponsor: Janssen Scientific Affairs, LLC

For more information, please contact: Our Research Team, 617.502.1707 or [email protected]

*Please note this Clinical Trial and Summary was started while AccessHealth MA was still known as Community Research Initiative (CRI). This information is still relevant.

Define Web Summary PDF

Contact our Research Team