Clinical Trials

CLINICAL TRIALS

CRI has several HIV and hepatitis C (HCV) clinical trials in progress at any one time at our Boston research facility. Clinical research helps find better ways to fight drug resistance and lower the possible harm from side effects. It also helps people stay on their drugs for as long as they need them and improves the simplicity of drug regimens so people can take fewer pills. Research improves the quality of HIV and HCV patient care on a global scale.

About clinical research trials

Clinical trials are supervised, scientific studies of new drugs to determine if they are safe and effective. These trials are the fastest and best way to find new treatments that might improve people’s health, and there are many safeguards in place to protect the rights and safety of people who volunteer to participate. To learn more about clinical research, click here.


Open and Enrolling clinical trials at CRI’s research facility in Boston

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 and HIV-positive, have an undetectable viral load, and 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. Please call Karen McLaughlin of CRI’s Research team at 617.502.1707 with any questions or to determine if you qualify.

 

If you would like updates about new, enrolling trials, please email info@crine.org and we will add you to our research updates email list.

 

Ongoing clinical trials at CRI’s research facility in Boston


Integrase STR
 – Ongoing; no longer enrolling
GS 380-1490

The Integrase STR study is 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.

 

[hr]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).

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Complera Switch – Ongoing; no longer enrolling
GS 366-1216

The Complera Switch study is examining the safety and effectiveness of an investigational single-tablet combination that contains three HIV medicines. This study is designed for adults who are HIV-positive and virologically suppressed on the single-tablet regimen FTC/RPV/TDF (Complera). Participants will be randomized to stay on Complera or switch to an investigational single-tablet regimen that contains the pro-drug tenofovir alafenamide (TAF) instead of tenofovir disoproxil fumarate (TDF), a component of Complera.

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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.

For more information about clinical trials at CRI, call 617.502.1700.