HIV research is important not only for the medical advancement of HIV treatment, but also for prevention. HIV disease is not without the possibility of multiple complications even with appropriate treatment. Therefore, further research is necessary to look at consequences of long-term therapy, and further adjunctive therapy to HIV treatment. There has been significant advancements over 25 years. From one drug therapy, we have now gone to a multiplicity of combinations available to us. This means that patients will live longer and be healthier. We are now moving into an era of prevention, not only of HIV disease itself but the long-term complications associated with long-term HIV treatment, as well as the aging process. This disease is definitely not going away, and it will require continued efforts in all age groups to look at all aspects of this disease.
Protocol GS-US-366-1992: A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects who switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs study (Co-infection treatment with Single Tablet Antiviral Regimens). Study Active; Screening Closed; 4 total subjects screened, 1 enrolled and 3 in screening process. December 2016
ViiV/GSK Injection Study. This is a phase III randomized study evaluating long acting injection medications in HIV patients. A very exciting opportunity as we look to the future in advancements of HIV medications.
Co-authored by VIIV Healthcare, a pharmaceutical company formed as a joint venture between Glaxo and Pfizer to specialize in HIV treatments, the GlaxoSmithKline trial is an injection study. “It’s looking at people who are doing fine on their medication but who we’re moving over to a monthly injection so as to minimize the side effects they experience,” Dr. Tanya Schreibman, Medical Director at the Sarasota headquarters clinic explains, “and as a result, increase their adherence to their therapy. People recently diagnosed are frequently on one pill once a day, and many of the patients who we’re considering for the trial are the newly diagnosed. But while medication has changed for them, it hasn’t changed for everyone. Especially not for someone who’s had the virus for a long time and might be on more medications and taking them more frequently. And there are older people with memory issues and people who just hate having to take their pills. All are eligible for this trial.”
NIH/National Institute of Allergy and Infectious Disease Statin Study. Randomized trial using statin medication to prevent vascular events in HIV.
Dr. Tanya Schreibman, Medical Director at the Sarasota headquarters clinic, is enrolling people in an NIH trial that is looking at the use of statins. Statins have long been used to control cholesterol in people with heart disease. But because statins are an anti-inflammatory and HIV is a general state of inflammation – one of the reasons those with HIV are at increased risk for hepatitis C, diabetes, heart disease and other co-morbidities – researchers are exploring the possibility that they may be an effective adjunct to treatment.
Dr. Schreibman states “We’re going to give a statin to people who are not already taking one and who otherwise wouldn’t meet the criteria for being prescribed a statin. We’re going to watch them for seven years against a control group on a placebo and see if they’re doing better with co-morbidities down the line than people not on the drug.”
Community Health is a satellite site for the Yale University Clinical Trials Program. We have done multiple collaborative studies in the past and will continue to do so in the future. Click here for more information on clinical research at CAN clinics.