Clinical Trials

We have been involved in many NIH networks conducting research in HIV, hepatitis C, hepatitis B, influenza, and COVID-19. We have done trials in substance use patients, outpatient HIV, outpatient COVID-19, inpatient COVID-19, and inpatient and outpatient influenza.

    Hepatitis B Network

    We were involved in sub-study of the hepatitis B network which focused on HIV/HBV patients. We enrolled, obtained liver biopsies, and followed patients for outcomes for 4 plus years. This multi-center collaboration produced multiple important insights into our knowledge of HIV/HBV.

    Reprieve (ACTG)

    We are involved in Reprieve trial which is a study examining if HIV patients at lower ASCVD risk would benefit from pitavastatin or not. This is a global study and patients are still being followed for clinical outcomes. 

     

    NIDA Clinical Trials Network

    We participated in Project Hope (CTN 0049) and HCV follow-up (CTN 0064). The initial study enrolled 801 patients in 10 centers in the US who were hospitalized and not on HIV medications and using substances. Patients were randomized to behavioral intervention to improve engagement in care. A follow-up study invited these participants back and tested for HCV and those who were positive were randomized to patient navigation vs. usual care.  Many new insights have been gained from this work. 

     

    Insight

    We participated in multiple studies through the INSIGHT NETWORK including START and Influenza studies.

    Influenza

    NIH ACTT Network

    We participated in COVID-19 trials in ACTT-2, ACTT-3, ACTT-4.

    • Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, Marconi VC, Ruiz-Palacios GM, Hsieh L, Kline S, Tapson V, Iovine NM, Jain MK, Sweeney DA, El Sahly HM, Branche AR, Regalado Pineda J, Lye DC, Sandkovsky U, Luetkemeyer AF, Cohen SH, Finberg RW, Jackson PEH, Taiwo B, Paules CI, Arguinchona H, Erdmann N, Ahuja N, Frank M, Oh MD, Kim ES, Tan SY, Mularski RA, Nielsen H, Ponce PO, Taylor BS, Larson L, Rouphael NG, Saklawi Y, Cantos VD, Ko ER, Engemann JJ, Amin AN, Watanabe M, Billings J, Elie MC, Davey RT, Burgess TH, Ferreira J, Green M, Makowski M, Cardoso A, de Bono S, Bonnett T, Proschan M, Deye GA, Dempsey W, Nayak SU, Dodd LE, Beigel JH; ACTT-2 Study Group Members. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med. 2021 Mar 4;384(9):795-807. doi: 10.1056/NEJMoa2031994. Epub 2020 Dec 11. PMID: 33306283; PMCID: PMC7745180.    
    • Kalil AC, Mehta AK, Patterson TF, Erdmann N, Gomez CA, Jain MK, Wolfe CR, Ruiz-Palacios GM, Kline S, Regalado Pineda J, Luetkemeyer AF, Harkins MS, Jackson PEH, Iovine NM, Tapson VF, Oh MD, Whitaker JA, Mularski RA, Paules CI, Ince D, Takasaki J, Sweeney DA, Sandkovsky U, Wyles DL, Hohmann E, Grimes KA, Grossberg R, Laguio-Vila M, Lambert AA, Lopez de Castilla D, Kim E, Larson L, Wan CR, Traenkner JJ, Ponce PO, Patterson JE, Goepfert PA, Sofarelli TA, Mocherla S, Ko ER, Ponce de Leon A, Doernberg SB, Atmar RL, Maves RC, Dangond F, Ferreira J, Green M, Makowski M, Bonnett T, Beresnev T, Ghazaryan V, Dempsey W, Nayak SU, Dodd L, Tomashek KM, Beigel JH; ACTT-3 study group members. Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Dec;9(12):1365-1376. doi: 10.1016/S2213-2600(21)00384-2. Epub 2021 Oct 18. PMID: 34672949; PMCID: PMC8523116.
    • Wolfe CR, Tomashek KM, Patterson TF, Gomez CA, Marconi VC, Jain MK, Yang OO, Paules CI, Palacios GMR, Grossberg R, Harkins MS, Mularski RA, Erdmann N, Sandkovsky U, Almasri E, Pineda JR, Dretler AW, de Castilla DL, Branche AR, Park PK, Mehta AK, Short WR, McLellan SLF, Kline S, Iovine NM, El Sahly HM, Doernberg SB, Oh MD, Huprikar N, Hohmann E, Kelley CF, Holodniy M, Kim ES, Sweeney DA, Finberg RW, Grimes KA, Maves RC, Ko ER, Engemann JJ, Taylor BS, Ponce PO, Larson L, Melendez DP, Seibert AM, Rouphael NG, Strebe J, Clark JL, Julian KG, de Leon AP, Cardoso A, de Bono S, Atmar RL, Ganesan A, Ferreira JL, Green M, Makowski M, Bonnett T, Beresnev T, Ghazaryan V, Dempsey W, Nayak SU, Dodd LE, Beigel JH, Kalil AC; ACTT-4 Study Group. Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial. Lancet Respir Med. 2022 May 23:S2213-2600(22)00088-1. doi: 10.1016/S2213-2600(22)00088-1. Epub ahead of print.; PMCID: PMC9126560
    NIH ACTIV-3 Network

    We participated in COVID-19 trials focused on testing new therapeutics for hospitalized patients through ACTIV-3 Network.

    NIH STRIVE Network

    We participating currently in the STRIVE (Strategies and Treatments for Respiratory Infections and Viral Emergencies) Network which is a group of research studies to investigate drugs and treatment strategies for adults in the hospital with respiratory or lung infections.

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