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

Switch 4030 – Ongoing; enrolling
This is a Phase III, randomized, double-blind study evaluating the safety and efficacy of switching from a regimen of Dolutegravir plus either Emtricitabine/Tenofovir Alafenamide (Descovy) or Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) to an investigational fixed-dose combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide. Participants will be randomized in a 1:1 ratio to receive the investigational HIV medication regimen Bictegravir/Emtricitabine/Tenofovir Alafenamide or the approved medicines Dolutegravir and Emtricitabine/Tenofovir Alafenamide (Descovy). Each subject will take a total of three pills once daily.

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.

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).

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.

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.