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Table of contents study category page clinical trial 2 behavioral/epidemiologic 43 basic science/virology 71


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FLORIDA CONSORTIUM FOR HIV/AIDS RESEARCH (FCHAR)

INVENTORY OF HIV/AIDS RESEARCH IN FLORIDA


TABLE OF CONTENTS

STUDY CATEGORY Page
CLINICAL TRIAL 2
BEHAVIORAL/EPIDEMIOLOGIC 43
BASIC SCIENCE/VIROLOGY 71

Clinical Trials




Community AIDS Resource, Inc. (Care Resource) – 5 studies

3510 Biscayne Boulevard, Suite 300

Miami, FL 33137




MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY


ViiV HealthCare/Pfizer - A4001095: A multicenter, randomized, double-blind, comparative trial of Maraviroc+Darunavir /Ritonavir versus Emtricitabine/Tenofovir + Darunavir /Ritonavir for the treatment of antiretroviral-naïve HIV infected patients with CCR5 Tropic HIV-1

NCT01345630(?)

PI: Steven Santiago, M.D
Contacts for further information:

Leandro Pisani

305/576-1234 ext 276

lpisani@careresource.org

or

Milagros Rodriguez



305/576-1234 ext 244

mrodriguez@careresource.org



Recruitment Begins 9/15/2011



MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
ELIGIBILITY :

Men and women ≥ 18 yrs of age who have never taken antiretroviral drugs and have a viral load > 1000 copies/ml and

CD4 > 100 cells/mm3





MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY


Tobira Therapeutics -652-2-202: A phase 2b,

multicenter, double blind comparative study to evaluate the efficacy, safety and tolerability of Cenicriviroc in HIV‐1 infected, antiretroviral treatment‐naïve patients with only CCR5‐tropic virus. Participants will receive either once‐daily 100 mg or 200 mg doses of Cenicriviroc in combination with Truvada or once‐daily Sustiva plus Truvada.

PI: Steven Santiago, M.D
Contacts for further information:

Leandro Pisani

305/576-1234 ext 276

lpisani@careresource.org

or

Milagros Rodriguez



305/576-1234 ext 244

mrodriguez@careresource.org




Recruitment Begins 8/20/2011

MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:

Men and women >

18 years of age with CCR5-tropic virus by GT and Trofile-ES who have never taken antiretroviral drugs; viral load > 5,000 copies/ml and CD4 > 250 cells/mm3






MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY


Viiv HealthCare/ Pfizer - A4001098: A multi-center, randomized, blinded, placebo-controlled study to evaluate the safety of Maraviroc in combination with other antiretroviral agents in HIV-1-infected subjects co-infected with Hepatitis C and/or Hepatitis B virus.

PI: Luis Saenz D.O
Contacts for further information:

Leandro Pisani

305/576-1234 ext 276

lpisani@careresource.org

or

Milagros Rodriguez



305/576-1234 ext 244

mrodriguez@careresource.org




Enrollment Open

MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:

≥ 18 yrs of age co-infected with Hepatitis C or B and not receiving treatment. for Hepatitis B or C. Undectectable viral load for at least 3 months. No prior treatment with Maraviroc or another CCR5








MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY

EPZ113734 - A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying from a Regimen of Atazanavir + Ritonavir + Tenofovir/Emtricitabine to Atazanavir + Abacavir/Lamivudine Without Ritonavir for 48



PI: Steven Santiago, M.D.

Luis Saenz D.O.

Contacts for further information:

Milagros Rodriguez

305/576-1234 ext 244

mrodriguez@careresource.org






MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY




MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)


GlaxoSmithKline -EPZ113734: A prospective, randomized, multicenter, open-label study to compare the efficacy and safety of simplifying from a regimen of Atazanavir + Ritonavir/Tenofovir/ Emtricitabine to Atazanavir + Abacavir/ Lamivudine without Ritonovir for 48 weeks in virologically suppressed, HIV-infected HLA-B 5701 negative subjects

PI: Steven Santiago, M.D.
Contacts for further information:

Leandro Pisani

305/576-1234 ext 276

lpisani@careresource.org

or

Milagros Rodriguez



305/576-1234 ext 244

mrodriguez@careresource.org




Enrollment Open

MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:

18 yrs of age who have been undetectable for more than 3 months and receiving a regimen of ATV/RTV (300mg/100 mg) +TDF/FTC (300mg/200 mg) as initial or first and only switch regimen for at least 6 months.








































































































































































































































































































































































































































































































































































































UNIVERSITY OF CENTRAL FLORIDA – 1 study

Presenter: Alexander M. Cole, Ph.D.



clinical Trial

Contract with HIV Vaccine Trials Network (HVTN) and Fred Hutchinson Cancer Research Center to process specimens for study# HVTN505

Alexander M. Cole, Ph.D. (PI of lab contract); Edwin DeJesus, M.D. (PI of clinical contract)

Microbiology and Molecular Biology

cGLP laboratory processing for clinical trial

NOVA SOUTHEASTERN UNIVERSITY – 6 studies

Presenter: Isa Fernandez, Ph.D.



clinical Trial

Young Hispanic Men – Entre Culturas: Navigating Culture, Identity and HIV Risk

Maria Isabel Fernandez, Ph.D. G. Stephen Bowen, M.D.

College of Osteopathic Medicine

HIV prevention among young Hispanic/Latino MSM

clinical Trial

Project POWER: A Health Promotion and HIV Risk Reduction Intervention for Black Men.

Maria Isabel Fernandez, Ph.D

College of Osteopathic Medicine

HIV prevention among black men who have sex with men and women

clinical Trial

Adolescent Trials Network for HIV interventions

Maria Isabel Fernandez, Ph.D. G.

College of Osteopathic Medicine

HIV and adolescents (both infected and at risk for HIV)

clinical Trial

Risk Reduction for Urban Substance Using MSM

Steven P. Kurtz, Ron Stall, Hilary L. Surratt

Division of Applied Interdisciplinary Studies

HIV, MSM, drug use National Institute on Drug Abuse Grant # DA024579

clinical Trial

A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV

Steven P. Kurtz, Hilary L. Surratt

Division of Applied Interdisciplinary Studies

HIV, young adults, drug use National Institute on Drug Abuse Grant # DA019048

clinical Trial

Case Management Alternatives for African American Women at High Risk for HIV

Hilary L. Surratt, Gladys Ibanez

Division of Applied Interdisciplinary Studies

HIV, women, drug use National Institute on Drug Abuse Grant # DA013131
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