ONGOING TRIALS

HBV Bio Sample – Ongoing and enrolling
The purpose of this study is to build a repository of blood samples obtained from people who are at high risk for acquiring hepatitis B (HBV) infection due to having certain clinical/medical conditions; occupational, behavioral, or sexual risks; or living in areas known to be endemic for HBV infection. The repository will be used to evaluate the performance of a diagnostic test for HBV infection.

DAASH – Ongoing and enrolling
This is a pilot study to investigate the effectiveness of HCV treatment with velpatasvir/sofosbuvir administered by psychiatrist/licensed buprenorphine/naloxone providers during regularly scheduled visits to an outpatient addiction clinic for buprenorphine/naloxone replacement therapy and mental healthcare, as measured by percentage of patients achieving SVR-12 (defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of study treatment.)

ATLAS 2M – Ongoing (no longer enrolling)
This study will evaluate the safety and effectiveness of switching to long-acting cabotegravir (CAB LA) and long-acting rilpivirine (RPV LA) administered every eight weeks compared to CAB LA + RPV LA administered every four weeks (Q4W) over a 48-week treatment period in approximately 1,020 adult HIV-1 infected subjects. Participants will receive injections of the medication every four or eight weeks onsite at CRI’s research facility in Boston.

Switch 4030 – Ongoing (no longer enrolling)
GS-US-380-4030
Community Research Initiative is recruiting study participants for a new clinical trial examining the safety and tolerability of an investigational single-tablet combination HIV therapy. To qualify, participants must: Be at least 18 years old, be HIV-positive, have an undetectable viral load, have been on a regimen consisting of Tivicay and either Truvada or Descovy for at least six months. Participants will be asked to take 3 tablets once a day for the duration of the study. A modest stipend will be awarded upon completion of each study visit. The study medication and lab tests are provided. All study visits will take place at CRI’s new office in the Schrafft’s City Center at
529 Main Street, Suite 301, Boston, MA 02129.

Integrase STR – Ongoing (no longer enrolling)
GS 380-1490
Have you been diagnosed with HIV but not yet been treated? CRI is currently enrolling participants in a clinical trial evaluating how safe and effective an experimental once-daily medication is in treating HIV. The Integrase STR study is designed for people who are at least 18 years old, HIV-positive, and have never been on treatment. Participants are randomized to take a fixed dose combination of either the experimental HIV regimen (GS-9883/emtricitabine/tenofovir alafenamide or GS-9883/F/TAF) or the approved medicines dolutegravir + emtricitabine/tenofovir alafenamide (DTG + F/TAF). The study measures the safety, efficacy, and tolerability of the GS-9883/F/TAF regimen compared to the DTG + F/TAF regimen.

All study medications and study-required labs and exams are provided to participants through the study at no cost for the duration of 96 weeks, after which all participants will be given the option to receive the experimental GS-9883/F/TAF regimen for an additional 48 weeks. Participants may be eligible for a modest stipend for time and travel per completed study visit.
If you are over 18, living with HIV, and have not been on treatment, you may be eligible to participate! Please contact Joanne Delaney at jdelaney@crine.org or 617.502.1707 to find out more.

Emerald – Ongoing (no longer enrolling)
TMC114IFD3013
The Emerald study is comparing the efficacy, safety and tolerability of an experimental once-daily single-tablet treatment for HIV. The Emerald study is designed for people who are at least 18 years old, HIV-positive, and currently virologically suppressed on an antiretroviral regimen consisting of a boosted protease inhibitor combined with FTC/TDF (Truvada). Participants are randomized to stay on their current regimen, or switch to the experimental regimen (darunavir/cobicistat/emtricitabine/tenofovir alafenamide or D/C/F/TAF).

START – Ongoing (no longer enrolling)
The START (Strategic Timing of Antiretroviral Treatment) study will answer the question, “When should I start taking HIV medication?” Currently guidelines are not consistent as to when the best time to start treatment would be. Some practice guidelines state that it is okay to begin medication when a person’s CD4 count reaches 350, while others suggest offering treatment immediately no matter how high the CD4 count is at the time of diagnosis. START is a large, definitive study to determine whether individuals should begin treatment with high CD4 counts (above 500) or whether it is better to wait to start for a CD4 count of around 350.