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Clinical Research

clinical Reasearchclinical Reasearch

 

 

History

 

The AIDS Research and Treatment Center of the Treasure Coast (ARTCTC), which is now The Pierone Research Institute: a Whole Family Health Center Initiative, was founded By Dr. Gerald Pierone Jr. in Fort Pierce, Florida in 1995. Dr. Pierone’s vision was to provide high quality medical care for people living with HIV infection and to prevent transmission through testing, counseling, and education. The Pierone Research Institute provides our patients the opportunity to participate in important clinical trials, along with Dr. Pierone inspired protocols that he designed and submitted to FDA. Our team is committed to supporting ongoing research designed to aid in improving HIV treatment and ultimately discovering a cure. We offer our patients the opportunity to participate in various trials and studies. Collaborate with the Vaccine and Gene Therapy Institute in their basic science program that is aimed at finding a cure for HIV infection. Some of the clinical trials we work with are sponsored by pharmaceutical companies and are designed to evaluate the effectiveness of new medications for treatment of HIV infection. Other clinical trials are focused on treatments for some of the complications of HIV and previous treatments. Each trial varies from one visit to several visits to years of follow-up. Most require periodic laboratory tests and may also include questionnaires or other testing. There is no cost to the volunteer and some study sponsors offer some financial compensation, others do not. If you are interested in making a difference or wish to find out more about our research programs, please speak to your provider or call the research department at (772) 978-9556.

 

What is a clinical trial?

 

Clinical trials are research studies performed in individuals that are aimed at evaluating a medical, surgical, or behavioral intervention. Participants receive specific interventions according to the research plan or protocol created by the investigator. Clinical trials are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and or has less harmful side effects than the standard treatment. The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA). Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through an Expanded Access Program.

 

  • Trial Phases:
  • Phase 1 – Studies that are usually conducted during this phase are with a small group of healthy volunteers using an abundance of caution to judge its safety and side effects. The goal of phase 1 trials is to determine what the drug’s most frequent and serious adverse effects are and how the drug metabolizes/excreted.
  • Phase 2 – Studies are slightly larger groups for investigators to collect data and analyze. Phase 2 is heavily focused on the effectiveness of a treatment. For example, participants receiving a treatment will be compared to similar patients also in the same study who are receiving a placebo treatment or different treatment.
  • Phase 3 – Studies continue to monitor safety and effectiveness of a treatment but expand the testing pool significantly. Phase 3 studies begin manipulating dosages and introducing drug combinations. At the end of Phase 3 if the FDA feels trial results are positive, it will approve the drug or treatment.
  • Phase 4 – Studies occurring after the FDA has approved the drug/treatment. Phase 4 studies allow investigators to continue gathering information about a drugs safety, efficiency and optimal use .
  • Source: https://clinicaltrials.gov and https://nia.nih.gov
 

 

Status Study Style Description Condition Intervention
Active, Not Enrolling Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults Randomized Trial to Prevent Vascular Events in HIV- REPRIEVE (A5332) To study the efficacy of statins to reduce the risk of cardiovascular disease in HIV-infected patients. HIV Infections Tablets Injections
Active, Not Enrolling Strategic Timing of Antiretroviral Treatment (START) To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines. To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction. HIV- Infections  
Active, Not Enrolling Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naïve Adults The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults. HIV-1 Infections  
 
 

Closed but still IRB active trials:

 

1. This trial should be on the active but enrolled trials---- its completed on our end but not closed out so still “active phase” per sponsor https://clinicaltrials.gov/ct2/show/NCT03631732?term=Gilead+380-4580&draw=2&rank=1 Gilead 380-4580 HIV Gilead Sciences, Inc. / “A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of two Nucleos(t)ide Reverse Transcriptase Inhibitors (NRTI) plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in
Virologically-Suppressed, HIV-1 Infected African American Participants”

 

2. https://clinicaltrials.gov/ct2/show/NCT02009462?term=HIV+facial+lipoatrophy&draw=2&rank=3 – Dr. Pierone written protocol- completed study for HIV subjects with Facial Lipoatrophy. Phase 1 trial: Bellafill ® for the Treatment of HIV Associated Facial

 

3. https://clinicaltrials.gov/ct2/show/NCT02833844?id=NCT04027387+OR+NCT04223804+OR+NCT02344290+OR+NCT03299049+OR+NCT02951052+OR+NCT02607930+OR+NCT00867048+OR+NCT02833844&draw=2&rank=5&load=cart AMGEN- HIV Repatha trial 20130286- Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects with HIV and with Hyperlipidemia and/or Mixed Dyslipidemia

 

4. https://clinicaltrials.gov/ct2/show/NCT02397096?term=MK+1439A-024+DRIVE&draw=2&rank=1 completed trial: A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)