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.
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.
- Sterling RK, Wahed AS, King WC, Kleiner DK, Khalili M, Sulkowski M, Chung RT, Jain MK, Lisker-Melman M, Wong DK, Ghany M, and the HIV-HBV Cohort Study for the Hepatitis B Research Network. Spectrum of liver disease in hepatitis B (HBV) patients coinfected with human immunodefiency virus (HIV): results of the HBV/HIV cohort study. Am J Gastroenterol 2019;114:746-757 doi: 10.1038/s41395-018-0409-9. PMID 30410040
- Sterling RK, King WC, Wahed AS, Kleiner DE, Khalili M, Sulkowski M, Chung RT, Jain MK, Lisker-Melman M, Wong DK, Ghany MG; HIV-HBV Cohort Study of the Hepatitis B Research Network. Evaluating Noninvasive Markers to Identify Advanced Fibrosis by Liver Biopsy in HBV/HIV Co-infected Adults. Hepatology. 2020 Feb;71(2):411-421. doi: 10.1002/hep.30825. Epub 2019 Aug 19. PMID: 31220357; PMCID: PMC6923615.
- Khalili M, King WC, Kleiner DE, Jain MK, Chung RT, Sulkowski M, Lisker-Melman M, Wong DK, Ghany M, Sanyal A, Sterling RK. Fatty Liver Disease in a Prospective North American Cohort of Adults With Human Immunodeficiency Virus and Hepatitis B Virus Coinfection. Clin Infect Dis. 2021 Nov 2;73(9):e3275-e3285. doi: 10.1093/cid/ciaa1303. PMID: 32869840; PMCID: PMC8563226.
- Sterling RK, King WC, Khalili M, Kleiner DE, Hinerman AS, Sulkowski M, Chung RT, Jain MK, Lisker-Melman MA, Wong DK, Ghany MG; HBV-HIV Cohort Study of the Hepatitis B Research Network. Performance of Serum-Based Scores for Identification of Mild Hepatic Steatosis in HBV Mono-infected and HBV-HIV Co-infected Adults. Dig Dis Sci. 2022 Feb;67(2):676-688. doi: 10.1007/s10620-021-06860-3. Epub 2021 Feb 8. PMID: 33559089.
- Sterling RK, King WC, Khalili M, Chung RT, Sulkowski M, Jain MK, Lisker-Melman M, Ghany MG, Wong DK, Hinerman AS, Bhan AK, Wahed AS, Kleiner DE; HBV-HIV Cohort Study of the Hepatitis B Research Network. A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV-HIV Co-infected Adults in North America. Hepatology. 2021 Sep;74(3):1174-1189. doi: 10.1002/hep.31823. Epub 2021 Aug 25. PMID: 33743541; PMCID: PMC8597319.
- Khalili M, King WC, Kleiner DE, Chung RT, Bhan AK, Ghany MG, Sulkowski MS, Lisker-Melman M, Jain MK, Janssen HLA, Hinerman AS, Sanyal AJ, Sterling RK. Evolution of Fatty Liver Disease and Relationship With Lipoproteins and Clinical Outcomes in Hepatitis B/Human Immunodeficiency Virus Coinfection. Clin Infect Dis. 2021 Oct 25:ciab764. doi: 10.1093/cid/ciab764. Epub ahead of print. PMID: 34698347.
- Chung RT, King WC, Ghany MG, Lisker-Melman M, Hinerman AS, Khalili M, Sulkowski M, Jain MK, Choi EK, Nalesnik MA, Bhan AK, Cloherty G, Wong DK, Sterling RK; HBV-HIV Cohort Study of the Hepatitis B Research Network. A prospective cohort study of novel markers of hepatitis B virus replication in human immunodeficiency virus coinfection. Clin Gastroenterol Hepatol. 2021 Dec 29:S1542-3565(21)01362-8. doi: 10.1016/j.cgh.2021.12.038. Epub ahead of print. PMID: 34973459.
- Gizaw A, King WC, Hinerman AS, Chung RT, Lisker-Melman M, Ghany MG, Khalili M, Jain MK, Graham J, Swift-Scanlan T, Kleiner DE, Sulkowski M, Wong DK, Sterling RK; HIV-HBV Cohort Study of the Hepatitis B Research Network. A prospective cohort study of renal function and bone turnover in adults with hepatitis B virus (HBV)-HIV co-infection with high prevalence of tenofovir-based antiretroviral therapy use. HIV Med. 2022 May 16. doi: 10.1111/hiv.13322. Epub ahead of print. PMID: 35578388
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.
- Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245. PMID: 32645158; PMCID: PMC7347082.
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.
- Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellón PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial. JAMA. 2016; 316:156-70. PMID:27404184 PMCID: PMC5339876
- Nijhawan AE, Rosen-Metsch L, Zhang S, Feaster DJ, Gooden L, Jain MK, Walker R, Huffaker S, Josephson S, Mugavero MJ, Jacobs P, Daar ES, Sullivan M, del Rio C, Halm E. Clinical and sociobehavioral prediction model of 30-day hospital readmissions among HIV patients: beyond electronic health record data. J Acquir Immune Defic Syndr. 2019;8:330-341. doi: 10.1097/QAI.000000000000192PMID 30763292 PMCID: PMC6488219
- Summers NA, Colasanti JA, Feaster DJ, Armstrong WS, Rodriguez A, Jain MK, Jacobs P, Metsch LR, Del Rio C. Predictors for Poor Linkage to Care Among Hospitalized Persons Living with HIV and Co-Occurring Substance Use Disorder. AIDS Res Hum Retroviruses. 2020 May;36(5):406-414. doi: 10.1089/AID.2019.0153. Epub 2020 Mar 3. PMID: 31914790; PMCID: PMC7232662.
- Jacobs P, Feaster DJ, Pan Y, Gooden LK, Daar ES, Lucas GM, Jain MK, Marsh EL, Armstrong WS, Rodriguez A, Del Rio C, Metsch LR. Initiation of Antiretroviral Therapy in the Hospital Is Associated With Linkage to Human Immunodeficiency Virus (HIV) Care for Persons Living With HIV and Substance Use Disorder. Clin Infect Dis. 2021 Oct 5;73(7):e1982-e1990. doi: 10.1093/cid/ciaa838. PMID: 32569355; PMC8492224.
- Traynor SM, Metsch LR, Gooden L, Stitzer M, Matheson T, Tross S, Carrico AW, Jain MK, Del Rio C, Feaster DJ. Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use. Drug Alcohol Depend. 2021 Apr 1;221:108567. doi: 10.1016/j.drugalcdep.2021.108567. Epub 2021 Feb 3. PMID: 33610093; PMCID: PMC8067954.
- Metsch LR, Feaster DJ, Gooden LK, Masson C, Perlman DC, Jain MK, Matheson T, Nelson CM, Jacobs P, Tross S, Haynes L, Lucas GM, Colasanti JA, Rodriguez A, Drainoni ML, Osorio G, Nijhawan AE, Jacobson JM, Sullivan M, Metzger D, Vergara-Rodriguez P, Lubelchek R, Duan R, Batycki JN, Matthews AG, Munoz F, Jelstrom E, Mandler R, Del Rio C. Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064). Open Forum Infect Dis. 2021 Jun 27;8(8):ofab334. doi: 10.1093/ofid/ofab334. PMID: 34377726; PMCID: PMC8339611.
- Jacobs P, Feaster DJ, Pan Y, Gooden LK, Daar ES, Lucas GM, Jain MK, Marsh EL, Armstrong WS, Rodriguez A, Del Rio C, Metsch LR. Initiation of Antiretroviral Therapy in the Hospital Is Associated With Linkage to Human Immunodeficiency Virus (HIV) Care for Persons Living With HIV and Substance Use Disorder. Clin Infect Dis. 2021 Oct 5;73(7):e1982-e1990. doi: 10.1093/cid/ciaa838. PMID: 32569355; PMCID: PMC8492224.
- Gutkind S, Starbird LE, Murphy SM, Teixeira PA, Gooden LK, Matheson T, Feaster DJ, Jain MK, Masson CL, Perlman DC, Del Rio C, Metsch LR, Schackman BR. Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs. Drug Alcohol Depend. 2022 Jan 10;232:109265. doi: 10.1016/j.drugalcdep.2022.109265. Epub ahead of print. PMID: 35042101.
We participated in multiple studies through the INSIGHT NETWORK including START and Influenza studies.
- Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D for the International Network Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Therapy (START) trial. HIV Med 2015;16:109-118. PMID 25711329; PMCID4341954
- Borges AH, Neuhaus J, Babiker AG, Henry K, Jain MK, Palfreeman A, Mugyenyi P, Domingo P, Hoffmann C, Read TR, Pujari S, Meulbroek M, Johnson M, Wilkin T, Mitsuyasu R, and INSIGHT START Study Group. Immediate antiretroviral therapy reduces risk of infection-related cancer during early HIV infection. Clin Infect Dis 2016;63:1668-1676. PMID 27609756 PMCID: PMC5146718
- Peterson RL, Vock DM, Powers JH, Emery S, Cruz EF, Hunsberger S, Jain MK, Pett S, Neaton JD; INSIGHT FLU-IVIG Study Group. Analysis of an ordinal endpoint for use in evaluating treatments for severe influenza requiring hospitalization. Clin Trials 2017; 14: 264-276. PMID 28397569 PMCID: PMC552856
- Davey RT Jr, Fernández-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30. PMID: 31582358; PMCID: PMC6868512
- Ghazi L, Baker JV, Sharma S, Jain MK, Palfreeman A, Necsoi C, Murray DD, Neaton JD, Drawz PE, for the INSIGHT START Study Group. Role of inflammatory biomarkers in the prevalence and incidence of hyptertension among HIV-positive participants in the START trial. Am J Hypertens. 2020 Jan 1;33(1):43-52. doi: 10.1093/ajh/hpz132.
- ITAC (INSIGHT 013) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Jan 27;399(10324):530–40. doi: 10.1016/S0140-6736(22)00101-5. Epub ahead of print. PMID: 35093205; PMCID: PMC8797010.
Influenza
- Beigel JH, Aga E, Elie-Turenne MC, Cho J, Tebas P, Clark CL, Metcalf JP, Ozment C, Raviprakash K, Beeler J, Holley HP Jr, Warner S, Chorley C, Lane HC, Hughes MD, Davey RT Jr; IRC005 Study Team [member of Investigator team IRC005]. Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2019 Nov;7(11):941-950. doi: 10.1016/S2213-2600(19)30199-7. Epub 2019 Sep 30. PMID: 31582360; PMCID: PMC6941345.
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
We participated in COVID-19 trials focused on testing new therapeutics for hospitalized patients through ACTIV-3 Network.
- ACTIV-3/TICO LY-CoV555 Study Group, Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Østergaard L, Chang CC, Davey VJ, Goodman A, Higgs ES, Murray DD, Murray TA, Paredes R, Parmar MKB, Phillips AN, Reilly C, Sharma S, Dewar RL, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med. 2021 Mar 11;384(10):905-914. doi: 10.1056/NEJMoa2033130. Epub 2020 Dec 22. PMID: 33356051; PMCID: PMC7781100
- ACTIV-3/TICO Bamlanivimab Study Group*. Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial. Ann Intern Med. 2021 Dec 21. doi: 10.7326/M21-3507. Epub ahead of print. PMID: 34928698.
- ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial. Lancet Infect Dis. 2021 Dec 23:S1473-3099(21)00751-9. doi: 10.1016/S1473-3099(21)00751-9. Epub ahead of print. PMID: 34953520; PMCID: PMC8700279.
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.
