CRI currently has a number of innovative studies. One of the newest trials compares two single-tablet regimens, one established and one experimental, to learn if the experimental regimen is safe, effective, and tolerable.
For more information, contact Karen McLaughlin or Julia Green at 617.502.1707.
The STR vs. STR study compares two single-tablet regimens (STRs) for patients who are starting their first antiretroviral combination. It compares two versions of tenofovir. One version, called tenofovir DF, is already FDA-approved. An experimental version called tenofovir alafenamide (TAF) is designed to maintain the antiviral potency of tenofovir DF but, if successful, to have fewer side effects. The study compares the established STR elvitegravir/cobicistat/emtricitabine/tenofovir DF (called Stribild) with an experimental STR that is comprised of the same medications except that it includes the study drug TAF instead of tenofovir DF. The study compares these two STRs for safety, efficacy, and tolerability. The newer experimental one-pill combination has the potential to become an important new medication in HIV therapy as it would provide another simple, single-tablet treatment regimen.
The START (Strategic Timing ofAntiretroviral 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.
The FLU study investigates the effects of the H1N1 flu on HIV-positive individuals. It is an international study funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
Community Research Initiative (CRI) is an independent, nonprofit, community-based organization in New England dedicated to HIV clinical research, treatment education, and financial assistance for approved drug treatments and health insurance coverage.
For more information about CRI, please visit www.crine.org