Katherine Huppler Hullsiek, Ph.D.

RETIRED Senior Research Associate
Division of Biostatistics
School of Public Health

2221 University Ave SE, Suite 200
Minneapolis, Minnesota 55414


email: hulls003@umn.edu

My research interests include the design, conduct, and analysis of HIV-related clinical trials and the analysis of longitudinal cohort data related to AIDS comorbidity research. I was a biostatistician for projects to detect, prevent and treat cryptococcal meningitis and TB meningitis in Uganda, South Africa and Indonesia. I retired in July 2022.

Papers

  • DeSanto DJ, Bangdiwala AS, Van Schalkwyk E, Skipper C, Greene G, Paxton J, Huppler Hullsiek K, Mashau R, Rajasingham R, Boulware DR, Govender NP. Evaluation of the effectiveness of a South African laboratory cryptococcal antigen screening programme using a retrospective cohnort and a cluster randomized trial. BMJ Open 2022;12:e054057:doi: 10.1136/bmjopen-2021-054057.

  • Mitja O, Reis G, Boulware DR, Spivak AM, Sarwar A, Johnston C, Webb B, Hill MD< Smilth D, Kremsner P, Curran M, Carter D, Alexander J, Corvacho M, Lee TC, Hullsiek KH, McDonald E, Hess R, Huges M, Baeten JM, Schwartz I, Metz L, Richer L, Chew KW, Daar E, Wohld D, Dunne M. Hydroxychloroquine for treatment of non-hosptialized adults with COVID 19: a meta-analysis of individual participant data of randomized trials. Clin Transl Sci. 2023 Mar;16(3):524-535.

  • Levin AE, Bangdiwala AS, Nalintya E, Kagimu E, Kasibante J, Rutakingirwa MK, Mpoza E, Jjunju S, Nuwagira E, Naluyima R, Kirumira P, Hou C, Ssebambulidde K, Musubire AK, Williams DA, Abassi M, Muzoora C, Hullsiek KH Rajasingham R, Meya DB, Boulware DR, Skipper CP. Outpatient cryptococcal antigen screening is assoicated with favorable baseline characteristics and improved survival in persons with cryptococcal meningitis in Uganda. Clinical Infectious Diseases 2022, ciac599, https://doi.org/10.1093/cid/ciac599.

  • Skipper CP, Huppler Hullsiek K, Cresswell FV, Tadeo KK, Okirwoth M, Blackstad M, Hernandez-Alvarado N, Fernandez-Alarcon C, Walukaga S, Martyn E, Ellis J, Ssbambulidde K, Tugume L, Nuwagira E, Rhein J, Meya DB, Boulware DR, Schleiss MR. Cytomegalovirus as a risk factor for mortality in HIV-associated cryptococcal and tuberculous meningitis. International Journal Infectious Diseases 2022.

  • Skipper CP, Hullsiek K, Stadelman A, Williams DA, Ssebambulidde K, Okafor E, Tugume L, Nuwagira E, Akampuira A, Musubire AK, Abassi M, Muzoora C, Rhein J, Bouleare DR, Meya DB. Sterile Ceregralspinal Fluid Cultures at Cryptococcal Meningitis Diagnosis is Associated Wtih High Mortality. J Fungi (Basel). 2022 Dec 28:9(1):46.

  • Lofgren SM, Okafor EC, Colette AA, Pastick KA, Skipper CP, Pullen MF, Nicol MR, Bold TD, Bandiwala AS, Engen NW, Collins C, Williams DA, Axelrod ML, Thielson BK, Hullsiek KH, Boulware DR, Rajasingham F. Feasibility of SARS-CoV-2 antibody testing in remote outpatient trials. Open Form Infectious Diseases, published online 06Oct2021.

  • Lofgren SM, Nicol MR< Kandole TK, Castillo-Mancilla J, Anderson PL, Mpoza E, Tugume L, Bangdiwala AS, Ssebambulidde K, Hullsiek KH, Rhein J, Meya DB, Boulware DR. Short Communication: A Descritptive Analysis of Dried Blood Splot Adherence Testing Among Ugandans With HIV Presenting with Cryptoccal Meningitis. AIDS Res Hum Retroviruses. 2021 Jul:37(7):529-533.

  • Marais S, Cresswell FV, Hamers RL, te Brake LHM, Ganiem AR, Imran D, Bangdiwala A, Martyn E, Kasibante J, Kagimu E, Musubire A, Maharani K, Estiasari R, Kusumaningrum A, Kusumadjayanti N, Yunivita V, Naidoo K, Lessells R, Moosa Y, Svensson E, Hullsiek KH, Aarnoutse RE, Boulware DR, van Crevel R, Ruslami R, Meya DB. High dose oral rifampicin to improve survival from adjult tuberculous meningitis: a randomized, placebo-controlled double blinded phase III trial (the HARVEST study). Wellcome Open Res (2020). 4:190. (https://doi.org/10.12688/wellcomeopnres.15565.2).

  • Rajasingham R, Bangdiwala AS, Nicol MR< Skipper CP, Pastick KA, Axelrod ML, Pullen MF, Nascence AA, Williams DA, Engen NW, Okafor EC, Mayer IA, McDonald EG, Lee TC, Li P, MacKenzie LJ, Balko JM, Dunlop SJ, Hullsiek KH, Boulare DR, Lofgren SM. Hydroxycholorquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial. Doi: 10.1101/2020.09.8.20197327.

  • Pullen MF< Pastick KA, Williams DA, Nascene AA, Bangdiwala AS, Okafor EC, Hullsiek K, Skipper CP, Lofgren SM, Engen N, Abassi M, McDonald EG, Lee TC, Rajasingham R, Bouleare DR. Lessons Learned from Conducting Internet-Based Randomized Clinical Trials During a Global Pandemic. Open Forum Infect Dis. 2020 Dec 28:8(2).

  • Skipper CP, Atukunda M, Stadelman A, Engen NW, Bangdiwala AS, Hullsiek K, Abassi M, Rhein J, Nicol MR< Laker E, Williams DA, Mannino R, Matkovits T, Meya DB, Boulware DR. Phase I EnACT Trial of the Safety and Tolerability of a Novel Oral Formuation of Amphotericn B. Antimicrob Agend Cemother.. 2020 Sep 21:64(10).

  • Stadelman A, Ssebambulidde K, Tugume L, Pastick K, Hullsiek K, Lofgren S, Nuwagira E, Evans E, Williams D, Muzoora C, Meya D, Rajasingham R, Rhein J, Boulware DB. Impact of biological sex on cryptococcal meningitis mortality in Uganda and South Africa. Medical Mycology 2021 Jan 05. https://doi.org/10.1093/mmy/myaa108.

  • Rajasingham R, Bangdiwala AS, Nicol MR, Skipper CP, Pastick KA, Axelrod ML, Pullen MF, Nascene AA, Williams DA, Engen NW, Okafor EC, Rina BI, Mayer IA, McDonald EG, Lee TC, Li P, MacKenzie LF, Balko JM, Dunlop SF, Hullsiek KH, Boulware DR, Lofgren SM. Pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial. Clinical Infectious Diseases (2020). 72:11. https://doi.org/10.1093/cid/ciaa1571.

  • Okafor E, Hullsiek KH, Williams DA, Scriven JE, Rhein J, Nabeta HW, Musubire AK, Rajasingham R, Muzoora C, Schutz C, Meintjes G, Meya DB, Boulware DR. Correlation between blood and CSF compartment cytokines and chemokines in subjects with cryptococcal meningitis. Mediators of Inflammation 2020. medRxiv 2020.05.08.20095232.

  • Abassi M, Bangdiwala AS, Nuwagira E, Tadeo KK, Okirwoth M, Williams DA, Mpoza E, Tugume L, Ssebambulidde K, Hullsiek KH, Musubire AK, Muzoora C, Rhein J, Meya DB, Boulware DR. Cerebrospinal fluid lactate as a prognostic marker of disease severity and mortality in cryptococcal meningitis. Clinical Infectious Diseases 28Nov2020. https://doi.org/10.1093/cid/ciaa1749.

  • Skipper C, Atukunda M, Stadelman A, Engen N, Bangdiwala A, Huppler Hullsiek K, Abassi M, Rhein J, Nicol MR, Laker E, Williams DA, Mannino R, Matkovits T, Meya DB, Boulware DR. Safety and tolerability of a novel oral formulation of amphotericin B: Phase I EnACT Trial. Antimicrob Agents Chemother. 2020 Aug 3; PubMed PMID: 32747357.

  • Eneh P, Huppler Hullsiek K, Kiiza D, Rhein J, Meya DB, Boulware DR, Nicol MR. Prevalence and nature of potential drug-drug interactions among hosptialized HIV patients presenting with suspected meningitis in Uganda. BMC Infectious Diseases 05 Aug2020. 20:572.

  • Lofgren SM, Nicol MR, Bangdiwala AS, Pastick KA, Okafor EC, Skipper CP, Pullen MF, Engen NW, Abassi M, Williams DA, Nascene AA, Axelrod ML, Lother SA, MacKenzie LJ, Drobot G, Marten N, Cheng MP, Zarychanshi R, Schwartz IS, Silverman M, Chagla Z, Kelley LE McDonald EG, Lee TC, Hullsiek KH, Boulware DR, Rajasingham R. Safety of Hydroxychloroquine among Outpatient Clincial Trial Participants for COVID-19. medRxiv, 2020 Jul 23; PubMedID: 32743591. PubMed Central PMCID: PMC7386515.

  • Lother SA, Abassi M, Agostinis A, Bangdiwala AS, cheng MP, Drobot G, Engen N, Hullsiek KH, Kelly LE, Lee TC, Lofgren SM, MacKenzie LJ, Marten N, McDonald EG, Okafor EC, Pastick KA, Pullen MF, Rajasingham R, Schwartz I, SkipperCP, Turgeon AF, Zarychanski R, Boulware DR. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); study protocol for a pragmatic randomized-controlled trial. Canadian Journal of Anesthesiology 2020; 67:1201-1211.

  • Pullen M, Skipper C, Hullsiek K, Bangdiwala A, Pastick K, Okafor E, Lofgren S, Rajasingham R, Engen N, Galdys A, Williams D, Abassi M, Boulware D. Symptoms of COVID-19 Outpatients in the United States. Open Forum Infectious Diseases. 2020 July; 7(7).

  • Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC Rajasingham R, Boulware DR. Hydroxychlorquine in nonhospitalized adults with early COVID-19: A randomized trial. Annals of Internal Medicine 2020; 173(8):623-31.

  • Boulware DR, Mullen MF, Bangdiwala AS, Pastick, KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ,Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A randomized trial of hydroxychloroquine as postexposure prophylaxis for Covid-19. New England Journal of Medicine 2020; 383:517-525.

  • Boulware DR, Nalintya E, Rajasingham R, Kirumira P, Naluyima R, Turya F, Namanda S, Rutakingirwa MK, Skipper CP, Nikweri Y, Hullsiek KH, Bangdiwala AS, Meya DB. Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial. Med Mycol. 2020 May 16:myaa033. doi: 10.1093/mmy/myaa033. Online ahead of print.PMID: 32415846

  • Pullen MF, Hullsiek KH, Rhein J, Musubire AK, Tugume L, Nuwagira E, Abassi M, Ssebambulidde K, Mpoza E, Kiggundu R, Akampurira A, Nabeta HW, Schutz C, Evans EE, Rajasingham R, Skipper CP, Pastick KA, Williams DA, Morawski BM, Bangdiwala AS, Meintjes G, Muzoora C, Meya DB, Boulware DR. CSF early fungicidal activity as a surrogate endpoint for cryptococcal meningitis survival in clinical trials. Clin Infect Dis. 2020 Jan 8;PubMed PMID: 31912875.

  • Pastick KA, Bangdiwala AS, Abassi M, Flynn AG, Morawski BM, Musubire AK, Eneh PC, Schutz C, Taseera K, Rhein J, Hullsiek KH, Nicol MR, Vidal JE, Nakasujja N, Meintjes G, Muzoora C, Meya DB, Boulware DR. Seizures in Human Immunodeficiency Virus-Associated Cryptococcal Meningitis: Predictors and Outcomes. Open Forum Infect Dis. 2019 Nov 5;6(11):ofz478.

  • Rhein J, Huppler Hullsiek K, Tugume L, Nuwagira E, Mpoza E, Evans EE, Kiggundu R, Pastick KA, Ssebambulidde K, Akampurira A, Williams DA, Bangdiwala AS, Abassi M, Musubire AK, Nicol MR, Muzoora C, MEra DB, Boulware DR; ASTRO-CM team. Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomized placebo-controll, double-blind phase 3 trial. Lancet Infect Dis. 2019 Aug;10(8):843-851.

  • Ssebambulidde K, Bangdiwala AS, Kwizera R, Kandole TK, Tugume L, Kiggundu R, Mpoza E, Nuwagira E, Williams DA, Lofgren SM, Abassi M, Musubire AK, Cresswell FV, Rhein J, Muzoora C, Hullsiek KH, Boulware DR, Meya DB; ASTRO-CM team. Symptomatic cryptococcal antigenemia presenting as early cryptococcal meningitis with negative CSF analysis. Clinical Infectious Diseases, 2018 Sep 25.

  • Rhein J, Hullsiek KH, Evans EE, Tugume L, Nuwagira E, Ssebambulidde K, Kiggundu R, Mpoza E, Musubire AK, Bangdiwala AS, Bahr NC, Williams DA, Abassi M, Muzoora C, Meya DB, Boulware DR; ASTRO-CM study team. Detrimental Outcomes of Unmasking Cryptococcal Meningitis With Recent ART Initiation. Open Forum Infectious Diseases, 2018 May 24; 5(8).

  • Katende A, Mbwanji G, Faini D, Nyuri A, Kalinjuma A, Mnzava D, Hullsiek K, Rhein J, Weiser M, Meya D, Boulware D, Letang E. Short course amphotericin B in addition to sertraline and fluconazole for treatment of HIV-associated cryptococcal meningitis in rural Tanzania. Mycoses, 28 August 2019. https://doi.org/10.1111/myc.12995.

  • Ahimbisiwe C, Kwizera R, Ndyetukira JF, Kugonza F, Sadiq A, Huppler Hullsiek K, Williams DA, Rhein J, Boulware DB, Meya DB. Management of amphotericin-induced phlebitis among HIV patients with cryptococcal meningitis in a resource-limited setting: a prospective cohort study. BMC Infect Dis (2019). 19:558. https://doi.org/10.1186/512879-019-4209.7.

  • Tugume L, Rhein J, Huppler Hullsiek K, Mpoza E, Kiggundu R, Ssebambulidde K, Schutz C, Taseera K, Williams DA, Abassi M, Muzoora C, Musubire AK, Meintjes G, Meya DB, Boulware DR. HIV-associated cryptococcal meningitis occurring at relatively higher CD4 counts. The Journal of Infectious Diseases, 2019;219(6):877-83.

  • Sortino O, Huppler Hullsiek K, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser r, Schacker T, Sereti I, Baker JV. The effects of recombinant human lactoferrin on immune activation and the intestinal microbiome among persons living with human immunodeficiency virus and receiving antiretroviral therapy. The Journal of Infectious Diseases, 2019;219(12);1963-1968. https://doi.org/10.1093/infdis/jiz042.

  • Musubire AK, Meya DB, Rhein J, Meintjes G, Bohjanen PR, Nuwagira E, Muzoora C, Boulware DR, Huppler Hullsiek K. Blood neutrophil counts in HIV-infected patients with cryptococcal meningitis: association with mortality. PLOS ONE, 2018. https://doi.org/10.1371/journal.pone.0209337.

  • Peterson TE, Huppler Hullsiek K, Wyman Engen N, Kumarasamy N, Lebec AM, Liappis A, Papadopoulos A, Polizzotto MN, Schreiner PF, Duprez D, Baker JV. Inflammation associates with impaired small arterial elasticity early in HIV disease. Open Forum Infectious Diseases June 2018; Volume 5, Issue 6.

  • Diehl JW, Hullsiek KH , Okirwoth M, Stephens N, Abassi M, Rhein J, Meya DB, Boulware DR, Musubire AK. Cerebral oximetry for detecting high-mortality risk patients with cryptococcal meningitis. Open Forum Infectious Diseases 2018, Volume 5, Issue 6.

  • Nalintya E, Meya DB, Lofgren S, Huppler Hullsiek K, Boulware DR, Rajasingham R. A prospective evaluation of a cryptococcal screening and treatment program in HIV clinics in Uganda. J Acquir Immunde Defic Syndr 2018; 78(2);231-238.

  • Schutz C, Boulware DR, Huppler Hullsiek K, von Hohenberg M, Rhein J, Taseera K, Thienemann F, Muzoora C, Meya DB, Meintjes G. Acute kidney injury and urinary biomarkers in human immunodeficiency virus-associated cryptococcal meningitis. Open Forum Infectious Diseases 2017. https://doi.org/10.1093/ofid/ofx127.

  • Montgomery MP, Nakasujja N, Morowski BM, Rajasingham R, Rhein J, Nalintya E, Williams DA, Huppler Hullsiek K, Kiragga A, Rolfes MA, Carlson RD, Bahr NC, Birkenkamp KE, Manabe YC, Bohjanen PR, Kaplan JE, Kambugu A, Meya DB, Boulware DR. Neurocognitive function in HIV-infected persons with asymptomatic cryptococcal antigenemia: a comparison of three prospective cohorts. BMC Neurology 2017 17:110. Doi:10.1186/s12883-017-0878-2.

  • Manion M, Huppler Hullsiek K, Wilson EMP, Rhame F, Kocic E, Gibson D, Hammer J, Patel P, Brooks JT, Baker FV, Sereti I. Vitamin D deficiency is associated with IL-6 levels and monocyte activation in HIV-infected persons. PLOS ONE 2017; https://doi.org/10.1371/journal/pone.0175517.

  • Flynn AG, Meya DB, Hullsiek KH, Rhein J, Williams DA, Musubire A, Morawski BM, Taseera K, Sadiq A, Ndyantunga L, Roediger M, Rajasingham R, Bohjanen PR, Muzoora C, Bouleware DR. Evolving Failures in the Delivery of Human Immunodeficiency Virus Care: Lessons From a Ugandan Meningitis Cohort 2006-2016. Open Forum Infect Dis. 2017 Apr 19;4(2):ofx077.

  • Lofgren S, Huppler Hullsiek K, Borawski BM, Nabeta HW, Kiggundu R, Taseera K, Musubire A, Schutz C, Abassa M, Bahr NC, Tugume L, Muzoora C, Williams DA, Rolfes MA, Velamakanni SS, Rajasingham R, Meintjes, G, Rhein J, Meya DB, Boulware DR. Differences in immunologic factors among those presenting with altered mental status in cryptococcal meningitis. Journal of Infectious Diseases 2017; 215(5):693-697.

  • Tugume L, Morawski B, Abassi M, Bahr N, Kiggundu R, Nabeta H, Huppler Hullsiek K, Taseera K, Musubire A, Schutz C, Muzoora C, Williams D, Rolfes M, Meintjes G, Rhein J, Meya D, Boulware DB. Prognostic implications of baseline anemia and changes in hemoglobin concentrations with amphotericin B therapy for cryptococcal meningitis. HIV Medicine 2016;18(1):13-20.

  • Baker JV, Huppler Hullsiek K, Engen NW, Nelson R, Chetchotisakd P, Gerstoft J, Jessen H, Losso M, Markowitz N, Munderi P, Papadopoulos A, Shuter J, Rappoport C, Pearson MT, Finley E, Babiker A, Emery S, Duprez D. Early antiretroviral therapy at hight CD4 counts does not improve arterial elasticity: a substudy of the Strategic Timing of AntiRetroviral Treatment (START) Trial. Open Forum Infectious Diseases 2016. DOI: 10.1093/ofid/ofw213.

  • Rhein R, Morawski BM, Huppler Hullsiek K, Nabeta HW, Kiggundu R, Tugume L, Musubire A, Akampurira A, Smith KD, Alhadab A, Williams DA, Abassi M, Bahr NC, Velamakanni SS, Fisher J, Nielsen K, Meya DB, Boulware DR. Efficay of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study. Lancet Infectious Diseases 2016;16(7):809-818.

  • Borges AH, Lundh A, Tendal B, Bartlett JA, Clumeck N, Costagliola D, Daar ES, Echeverria P, Gisslen M, Huedo-Medina TB, Hughes M, Huppler Hullsiek K, Khabo P, Komati S, Kumar P, Lockman S, MacArthur RD, Maggilo F, Matteelli A, Miro JM, Oka S, Petoumenos K, Puls RL, Riddler SA, Sax PE, Sierra-Madero J, Torti C, Lundgren JD. Non-nucleoside reverse transcriptase inhibitor- versus ritonavir-boosted protease inhibitor-based regmens for initial treatment of HIV infection: a systematic review and meta-analysis of randomized trials. Clinical Infectious Diseases 2016;63(2):268-280.

  • Boulware DR, von Hohenberg M, Rolfes MA, Bahr NC, Rhein J, Akampurira A, Williams DA, Taseera D, Schutz C, McDonald T, muzoora C, Meintjes G, Meya DB, Nielsen K, Huppler Hullsiek K. Human Immune Respose Varies by the Degree of Relative Cryptococal Antigen Shedding. Open Forum Infectious Diseases 2015; doi: 10.1093/ofid/ofv194.

  • Smith KD, Achan B, Huppler Hullsiek K, McDonald T, Okagaki LH, Akampurira A, Rhein JR, Meya DB, Boulware DR, Nielsen K. Increased antifungal drug resistance in Ugandan clinical isolates of Cryptococcus neoformans. Antimicrobial Agents and Chemotherapy 2015; 59: 12 7197-7204.

  • Kiggundu R, Morawski BM, Bahr NC, Rhein J, Musubire AK, Williams DA, Abassi M, Nabeta HW, Huppler Hullsiek K, Meya DB, Boulware DR. Effects of tenofovir and amphotericin B deoxycholate co-administration on kidney function in patients treated for cryptococcal meningitis. JAIDS 2016; 71(1): 65-69.

  • Rolfes MA, Rhein J, Schutz C, Taseera K, Nabeta HW, Huppler Hullsiek K, Akampuira A, Rajasingham R, Musubire A, Williams DA, Thienemann F, Bohjanen PR, Muzoora C, Meintjes G, Meya DB, Boulware DR. Cerebrospinal Fluid Culture Positivity and Clinical Outcomes After Amphotericin-Based Induction Therapy for Cryptococcal Meningitis. Open Forum Infectious Diseases 2015; doi: 10.1093/ofid/ofv157.

  • Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S and Duprez D. Assessment of arterial elasticity among HIV-postivie participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Medicine 2015; 16 (Suppl. 1), 109-118.

  • Scriven JE, Rhein J, Huppler Hullsiek K, von Hohenberg M, Linder G, Rolfes MA, Williams DA, Tasseera K, Meya D, Meintjes G, Boulware DR. Early ART after cryptococcal meningitis is associated with cerebrospinal fluid pleocytosis and macrophage activation in a multisite randomized trial. Journal of Infectious Diseases 2015; 212:769-778.

  • Huppler Hullsiek K, Kagan JM, Engen N, Grarup J, Hudson F, Denning ET, Carey C, Courtney-Rodgers D, Finley EB, Jansson PO, Pearson MT, Peavy DE, Belloso WH. Investigating the efficacy of clinical trial monitoring strategies: design and implementation of the cluster randomized START Monitoring Substudy. Therapeutic Innovation & Regulatory Science, 2014. DOI: 10.1177/2168479014555912.

  • Rolfes MA, Huppler Hullsiek K, Rhein J, Nabeta HW, Taseera K, Schutz C, Musubire A, Rajasingham R, Williams DA, Thienemann F, Muzoora C, Meintjes G, Meya DB, Boulware DB. The effect of therapeutic lumbar punctures on acute mortality from cryptococcal meningitis. Clinical Infectious Diseases, 2014; 59(11):1607-1614.

  • Wilson EM, Singh A, Huppler Hullsiek K, Gibson D, Wenry WK, Lichtenstein K, Onon NF, Kijic E, Patel P, Brooks JT, Sereti I, Baker JV. Monocyte activation phenotypes are associated with biomarkers of inflammation and coagulation in chronic HIV infection. Journal of Infectious Diseases, May 2014; 210(9):1396-1406.

  • Boulware DR, Meya DB, Muzoora C, Rolfes MA, Huppler Hullsiek K, Musubire A, Taseera K, Nabeta HW, Schutz C, Williams DA, Rajasingham R, Rhein J, Thienemann F, Lo MW, Nielson K, Bergemann TL, Kambuga A, Manabe YC, Janoff EN, Bohjanen PR, Meintjes G. Timing of antiretroviral therapy after cryptococcal meningitis. New England Journal of Medicine 2014; 370(26): 2487-2498.

  • Miller CJ, Baker JV, Bormann AM, Erlandson KM, Huppler Hullsiek K, Justice AC, Neuhaus J, Paredes R, Petouremos K Wentworth D, Winston A, Wolfson J, Neaton J. Adjudicated morbidity and mortality outcomes by age among individuals with HIV infection on suppressive antiretroviral therapy. Plos One, 2014: 9(4):395061.

  • Alozie O, Prosser R, Huppler Hullsiek K, Duprez D, Rhame F, Henry K and Baker JV. Switching from abacavir/lamivudine to tenofovirDF/emtricitabine reduces biomarkers of inflammation. J AIDS Clin Res, 2014; 5(2):278 doi:10.4172/2155-6113.1000278.

  • Baker JV, Huppler Hullsiek K, Singh A, Wilson E, Henry WK, Lichtenstein K, Onen N, Kojic E, Patel P, Brooks JT, Hodis H, Budoff M, Sereti I. Immunologic predictors of coronary artery calcium progression in a contemporary HIV cohort. AIDS, 2013; 63(3):367-371.

  • Baker JV, Huppler Hullsiek K, Bradford RL, Prosser R, Tracy RP, Key NS. Circulating levels of tissue factor microparticle pro-coagulant activity are reduced with antiretroviral therapy and associated with persistent inflammation and coagulation among HIV positive patients. JAIDS, 2013; 63(3): 367-371.

  • Andrade BB, Huppler Hullsiek K, Boulware DR, Rupert A, French MA, Ruxrungthan K, Montes ML, Price H, Barreiro P, Audsley J, Sher A, Lewin SR, Sereti I. Biomarkers of inflammation and coagulation are associated with mortality and hepatitis flares in persons coinfected with HIV and hepatitis viruses. Journal of Infectious Diseases, 2013; 207(9): 1379-1388.

  • Li JZ, Paredes R, Ribaudo H, Kozal MJ, Svarovskaia ES, Johnson JA, Geretti AM, Metzner KJ, Jakobsen M, Huppler Hullsiek K, Ostergaard L, Miller MD, Kuritzkes DR. Impact of minority nonnucleoside reverse transriptase inhibitor resistance mutations on resistance genotype after virologic failure. Journal of Infectious Diseases, 2013; 207(6): 893-897.

  • Ganesan A, Krantz EM, Huppler Hullsiek K, Riddle MS, Weingtrob AC, Lalani T, Okulicz JF, Landrum M, Agan B, Whitman TJ, Ross MF, Crum-Cianflone NF. Determinants of incident chronic kidney disease and progression in a cohort of HIV-infected persons with unrestricted access to health care. HIV Medicine, 2013; 14(2): 65-76.

  • Baker JV, Huppler Hullsiek K, Prosser R, Duprez D, Grimm R, Tracey RP, Rhame F, Henry K, Neaton JD. Angiotensin converting enzyme inhibitor and HMG-CoA reductase inhibitor as adjunct treatment for persons with HIV infection: a feasibility randomized trial. Plos One, 2012; 7(10);e46894.

  • Landrum ML, Huppler Hullsiek K, O'Connell RJ, Chun HM, Ganesan A, Okulicz JF, Lalani T, Weintrob AC, Crum-Cianflone NF, Agan BK. Hepatitis B vaccine antibody response and the risk of clinical AIDS or death. Plos One, 2012: 7(3);e33488.

  • Chun HM, Roediger MP, Huppler Hullsiek K, Thio CL, Agan BK, Bradley WP, Peel SA, Jagodzinski LL, Weintrob AC, Ganesan A, Wortmann G, Crum-Cianflone NF, Maguire JD, Landrum ML. Hepatitis B virus co-infection negatively impacts HIV outcomes in HIV seroconverters. Journal of Infectious Diseases, 2012: 205:185-193.

  • Li JZ, Paredes R, Ribaudo HF, Svarovskaia ES, Kozal MJ, Huppler Hullsiek K, Miller MD, Bangsberg D, Kuritzkes D. Relationship between minority NNRT resistance mutations, adherence, and risk of virologic failure. AIDS, 2012: 26(2):185-192.

  • Huppler Hullsiek K, Grund B. Considerations for endpoint selection when designing HIV clinical trials. Current Infectious Disease Disease Reports, 2011. DOI 10.1007/s11908-011-0231-7.

  • Krantz EM, Huppler Hullsiek K, Okulicz JF, Weintrob AC, Agan BK, Crum-Cianflone NF, Ganesan A, Ferguson TM, HAle BR. Elevated CD8 counts during HAART are associated with HIV virologic treatment failure. JAIDS, 2011: 57(5);396-403.

  • Li JZ, Paredes R, Ribaudo HF, Svarovskaia ES, Metzner KJ, Kozal MJ, Huppler Hullsiek K, Balduin M, Jakobsen MR, Geretti AM, Thiebaut R, Ostergaard L, Masquelier B, Johnson JA, Miller MD, Kuritzkes D. Low-frequency HIV-1 drug resistance mutations and risk of NNRTI-based antiretroviral treatment failure. Journal of the American Medical Association, 2011: 305(13);1327-1335.

  • Boulware DR, Huppler Hullsiek K, Puronen CE, Rupter A, Baker JV, French MA, Bohjanen PR, Novak RM, Neaton JD, Sereti I. Higher levels of CRP, D-dimer, IL-6 and hyaluronic acid before initiation of antiretroviral therapy are associated with increased risk of AIDS or death. Journal of Infectious Diseases, 2011: 203;1637-1646.

  • Landrum ML, Huppler Hullsiek K, Chun HM, Crum-Cianflone NF, Ganesan A, Weintrob AC, Barthel V, Agan BK. The timing of hepatitis B virus (HBV) immunization relative to human immunodeficiency virus (HIV) diagnosis influences the risk of HBV infection following HIV diagnosis. American Journal of Epidemiology, 2011: 173(1);84-93.

  • Crum-Cianflone NF, Roediger M, Huppler Hullsiek K, Ganesan A, Landrum M, Weintrob A, Again B, Medina S, Rahkola J, Hale B, Janoff EN. The association of ethnicity with anitibody responses to pneumococcal vaccination among adults with HIV infection. Vaccine; 2010: 28;7583-7588.

  • Huppler Hullsiek K, George M, Brown SK. Designing and managing a flexible and dynamic biorepository system: A 15 year perspective from the CPCRA, ESPRIT, and INSIGHT clinical trial networks. Current Opinion in HIV and AIDS, 2010; 5(6): 538-544.

  • Crum-Cianflone NF, Huppler Hullsiek K, Ganesan A, Weintrob A, Okulicz J, Agan BK. Is Kaposi's sarcoma occurring at higher CD4 cell counts over the course of the HIV epidemic? AIDS 2010; 24(18):2881-2883.

  • Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum M, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine (PCV) to polysaccharide vaccine (PPV) among HIV-infected adults. Journal of Infectious Diseases 2010; 202:1114-1125.

  • Baker JV, Quick H, Huppler Hullsiek K, Tracy R, Duprez D, Henry K, Neaton JD. IL-6 and D-dimer levels are associated with vascular dysfunction in patients with untreated HIV infection. HIV Medicine 2010; 11(9):608-609.

  • Gardner EM, Huppler Hullsiek K, Telzak EE, Sharma S, Peng G, Burman WJ, MacArthur RD, Chesney M, Friedland G, Mannheimer SB. Antiretroviral medication adherence and class-specific resistance in a large prospective clincial trial. AIDS 2010;24(3):395-403.

  • Chun HM, Fieberg AM, Huppler Hullsiek K, Lifson AF, Crum-Cianflone NF, Weintrob AC, Ganesan A, Barthel RV, Bradley WP, Agan BK, Landrum ML. The epidemiology of hepatitis B virus infection in a U.S. cohort of HIV-infected individuals during the last 20 years. Clinical Infectious Disases, 2010; 50(3):426-436.

  • Baker J, Ayenew W, Quick H, Huppler Hullsiek K, Tracy R, Henry K, Duprez D, Neaton JD. High-density lipoprotein particles and markers of inflammation and thrombotic activity in patients with untreated HIV infection. Journal of Infectious Diseases, 2010; 201:285-292.

  • Crum-Cianflone NF, Huppler Hullsiek K, Marconi VC, Ganesan A, Weintrob A, Barthel RV, Agan BK. Anal cancers among HIV-infected persons: HAART is not slowing rising incidence. AIDS, 2010; 24(4):535-543..

  • Landrum ML, Huppler Hullsiek K, Ganesan A, Weintrob AC, Crum-Cianflone NF, Barthel V, O'Connell RJ, Fieberg A, Chun HM, Marconi VC, Dolan MJ, Agan BK. Hepatitis B vaccination and risk of hepatitis B infection in HIV-infected individuals. AIDS, 2010; 24(4):545-555.

  • Baker JV, Duprez D, Rapkin J, Huppler Hullsiek K, Quick H, Grimm R, Neaton JD, Henry K. Untreated HIV infection and large and small artery elasticity. JAIDS, 2009; 52(1):25-31.

  • Landrum ML, Huppler Hullsiek K, Ganesan A, Weintrob AC, Crum-Cianflone NF, Barthel RV, Peel S, Agan BK. Hepatitis B vaccine response in a large U.S. military cohort of HIV-infected individuals: another benefit of HAART in those with preserved CD4 count. Vaccine, 2009; 27:4731-4738.

  • Crum-Cianflone N, Huppler Hullsiek K, Satter E, Marconi V, Weintrob A, Ganesan A, Barthel RV, Fraser S, Agan B. Cutaneous malignancies among HIV-infected persons. Archives of Internal Medicine, 2009; 169(12):1130-1138.

  • Crum-Cianflone N, Huppler Hullsiek K, Marconi V, Weintrob A, Ganesan A, Barthel V, Fraser S, Poehlman Roediger M, Agan B, Wegner s. The impact of nelfinavir exposure on cancer development among a large cohort of HIV-infected patients. JAIDS, 2009; 51(3):305-309.

  • Simen B, Simons JF, Huppler Hullsiek K, Novak RM, MacArthur RD, Baxter JD, Huang C, Lubeski C, Turenchalk GS, Braverman MS, Desany B, Rothberg JM, Egholm M, Kozal MJ. Low abundance drug resistant variants in chronically HIV-infected antiretroviral naive patients significnatly impact treatment outcome. Journal of Infectious Diseases, 2009;199:693-701.

  • Crum-Cianflone NC, Huppler Hullsiek K, Marconi V, Weintrob A, Ganesan A, Barthel V, Fraser S, Agan B, Wegner S. Trends in the incidence of cancers among HIV-infected persons and the impact of antiretroviral therapy: a 20 year cohort study. AIDS, 2009; 23:41-50 .

  • van den Berg-Wolf M, Huppler Hullsiek K, Peng G, Kozal MJ, Novak RM, Chen L, Crane LR, MacArthur RD. Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1 infected persons. HIV Clinical Trials, 2008; 9:324-336.

  • Fox Z, Phillips A, Cohen C, Neuhaus J, Baxter J, Emery S, Hirschel B, Huppler Hullsiek K, Stephan C, Lundgren J. Viral resuppression and detection of drug resistance following interruption of a suppressive NNRTI-based regimen. AIDS, 2008; 22(17):2279-2289.

  • Mannheimer SB, Wold N, Gardner EM, Telzak EE, Huppler Hullsiek K, Chesney M, Wu AW, MacArthur RD, Matts J, Friedland G. Mild-to-moderate symptoms during the first year of antiretroviral therapy worsen quality of life in HIV-infected indivuals. Clinical Infectious Diseases, 2008; 46(6):941-5.

  • Mannheimer S, Thackeray L, Huppler Hullsiek K, Chesney M, Gardner E, Wu A, Telzak E, Lawrence J, Baxter J, Friedland G. A randomized comparison of two instruments for measuring self-reported adherence. AIDS Care, 2008; 20(2):161-169.

  • Gardner EM, Sharma S, Peng G, Huppler Hullsiek K, Burman WJ, MacArthur RD, Chesney M, Telzak EE, Friedland G, Mannheimer SB. Differential adherence to components of combination antiretroviral therapy is associated with virologic failure and antiretroviral resistance. AIDS, 2008; 22:75-82.

  • Kozal MJ, Huppler Hullsiek K, MacArthur RD, van den Berg-Wolf M, Peng G, Xiang Y, Baxter JD, Uy J. The incidence of HIV drug resistance and its impact on progression of HIV disease among antiretroviral-naive participants started on three different antiretroviral therapy strategies. HIV Clinical Trials, 2007; 8:357-370.

  • MacArthur RD, Novak RM, Peng G, Chen L, Xiang Y, Huppler Hullsiek K, Kozal MJ, van den Berg-Wolf M, Henely C, Schmetter B, Dehlinger M. A comparison of three highly active antiretroviral treatment strategies consisting of non-nucleoside reverse transcriptase inhibitors, protease inhibitors, or both in the presence of nucleoside reverse transcriptase inhibitors as initial therapy (CPCRA 058 FIRST Study): a long-term randomised trial. Lancet, 2006; 368:2125-2135.

  • Lawrence J, Huppler Hullsiek K, Thackeray L, Abrams D, Crane L, Mayers D, Jones M, Saldanha J, Schmetter B, Baxter J. Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: Final results of the CPCRA 064 Study. Journal of Acquired Immune Deficiency Syndromes, 2006; 43:169-178.

  • Kozal M, Huppler Hullsiek K, Leduc R, Novak R, MacArthur R, Lawrence J, Baxter J. Prevalence and impact of HIV-1 protease codon 33 mutations and polymorphisms in treatment-naive and treatment-experienced patients enrolling in clinical trials. Antiviral Therapy, 2006; 11:457-463.

  • Novak R, Chen L, MacArthur R, Baxter J, Huppler Hullsiek K, Peng G, Xiang Y, Henley C, Schmetter B, Uy J, van den Berg-Wolf M, Kozal M, and the Terry Beirn Community Programs for Clinical Research on AIDS 058 Study Team. Prevalence of antiretroviral drug resistance mutations in chronically human immunodeficiency virus-infected, treatment-naive patients: implications for routine resistance screening before initiation of antiretroviral therapy. Clinical Infectious Diseases, 2005; 40:468-474.

  • Lawrence J, Mayers D, Huppler Hullsiek K, Collins G, Abrams D, Reisler R, Crane L, Schmetter B, Dionne T, Saldanha J, Jones M, Baxter J. Structured treatment interruption in patients with multi-drug resistant Human immunodeficiency Virus. New England Journal of Medicine , 2003; 349:837-846.

  • Tedaldi E, Huppler Hullsiek K, Malvestutto C, Arduino R, Fisher E, Gaglio P, Jenny-Avital E, McGowan J, Perez G. Prevalence and characteristics of HCV coinfection in an HIV clinical trials group. Clinical Infectious Diseases. 2003; 36:1313-1317.

  • Han C, Pulling CC, Telke SE, Huppler Hullsiek K. Assessing the utility of five domains in the SF-12 Health Status questionnaire in an AIDS clinical trial. AIDS , 2002; 16:431-439.

  • Huppler Hullsiek K, Louis TA. Propensity score modeling strategies for the causal analysis of observational data. Biostatistics. 2002; 4:179-193.



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