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Design of vaccine efficacy trials during public health emergencies.

Dean NE, Gsell PS, Brookmeyer R, De Gruttola V, Donnelly CA, Halloran ME, Jasseh M, Nason M, Riveros X, Watson CH, Henao-Restrepo AM, Longini IM.

Sci Transl Med. 2019 Jul 3;11(499). pii: eaat0360. doi: 10.1126/scitranslmed.aat0360. Review.


Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy.

Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators.

N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.


Outcomes Following Pregnancy Conception on Antiretroviral Therapy: A Call for More Data.

Lockman S, De Gruttola V.

Clin Infect Dis. 2019 Jan 7;68(2):280-281. doi: 10.1093/cid/ciy703. No abstract available.


Primary Neural Degeneration in the Human Cochlea: Evidence for Hidden Hearing Loss in the Aging Ear.

Wu PZ, Liberman LD, Bennett K, de Gruttola V, O'Malley JT, Liberman MC.

Neuroscience. 2019 May 21;407:8-20. doi: 10.1016/j.neuroscience.2018.07.053. Epub 2018 Aug 10.


Antiretroviral Therapy and Mortality in Rural South Africa: A Comparison of Causal Modeling Approaches.

Oldenburg CE, Seage GR, Tanser F, De Gruttola V, Mayer KH, Mimiaga MJ, Bor J, Bärnighausen T.

Am J Epidemiol. 2018 Aug 1;187(8):1772-1779. doi: 10.1093/aje/kwy065.


Impact of early antiretroviral therapy eligibility on HIV acquisition: household-level evidence from rural South Africa.

Oldenburg CE, Bor J, Harling G, Tanser F, Mutevedzi T, Shahmanesh M, Seage GR, De Gruttola V, Mimiaga MJ, Mayer KH, Pillay D, Bärnighausen T.

AIDS. 2018 Mar 13;32(5):635-643. doi: 10.1097/QAD.0000000000001737.


High HIV-1 RNA Among Newly Diagnosed People in Botswana.

Novitsky V, Prague M, Moyo S, Gaolathe T, Mmalane M, Yankinda EK, Chakalisa U, Lebelonyane R, Khan N, Powis KM, Widenfelt E, Gaseitsiwe S, Dryden-Peterson SL, Holme MP, De Gruttola V, Bachanas P, Makhema J, Lockman S, Essex M.

AIDS Res Hum Retroviruses. 2018 Mar;34(3):300-306. doi: 10.1089/AID.2017.0214. Epub 2018 Jan 17.


Inference on network statistics by restricting to the network space: applications to sexual history data.

Goyal R, De Gruttola V.

Stat Med. 2018 Jan 30;37(2):218-235. doi: 10.1002/sim.7393. Epub 2017 Jul 25.


The use of permutation tests for the analysis of parallel and stepped-wedge cluster-randomized trials.

Wang R, De Gruttola V.

Stat Med. 2017 Aug 15;36(18):2831-2843. doi: 10.1002/sim.7329. Epub 2017 May 2.


Brief Report: Changes in Levels of Inflammation After Antiretroviral Treatment During Early HIV Infection in AIDS Clinical Trials Group Study A5217.

Macatangay BJ, Yang M, Sun X, Morton J, De Gruttola V, Little S, Hogan C, Rinaldo CR; A5217 Team.

J Acquir Immune Defic Syndr. 2017 May 1;75(1):137-141. doi: 10.1097/QAI.0000000000001320.


Leveraging contact network structure in the design of cluster randomized trials.

Harling G, Wang R, Onnela JP, De Gruttola V.

Clin Trials. 2017 Feb;14(1):37-47. doi: 10.1177/1740774516673355. Epub 2016 Oct 24.


Reply to Cohen et al.

Oldenburg CE, Bärnighausen T, Tanser F, Iwuji CC, De Gruttola V, Seage GR 3rd, Mimiaga MJ, Mayer KH, Pillay D, Harling G.

Clin Infect Dis. 2016 Dec 15;63(12):1680. Epub 2016 Sep 29. No abstract available.


Antiretroviral Therapy to Prevent HIV Acquisition in Serodiscordant Couples in a Hyperendemic Community in Rural South Africa.

Oldenburg CE, Bärnighausen T, Tanser F, Iwuji CC, De Gruttola V, Seage GR 3rd, Mimiaga MJ, Mayer KH, Pillay D, Harling G.

Clin Infect Dis. 2016 Aug 15;63(4):548-54. doi: 10.1093/cid/ciw335. Epub 2016 May 20.


Viral Genetic Linkage Analysis in the Presence of Missing Data.

Liu SH, Erion G, Novitsky V, De Gruttola V.

PLoS One. 2015 Aug 24;10(8):e0135469. doi: 10.1371/journal.pone.0135469. eCollection 2015.


Sampling dynamic networks with application to investigation of HIV epidemic drivers.

Goyal R, De Gruttola V.

Math Biosci. 2015 Sep;267:124-33. doi: 10.1016/j.mbs.2015.06.013. Epub 2015 Jul 19.


Sampling Networks from Their Posterior Predictive Distribution.

Goyal R, De Gruttola V, Blitzstein J.

Netw Sci (Camb Univ Press). 2014 Apr 1;2(1):107-131.


Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial.

Safren SA, Biello KB, Smeaton L, Mimiaga MJ, Walawander A, Lama JR, Rana A, Nyirenda M, Kayoyo VM, Samaneka W, Joglekar A, Celentano D, Martinez A, Remmert JE, Nair A, Lalloo UG, Kumarasamy N, Hakim J, Campbell TB; PEARLS (ACTG A5175) Study Team.

PLoS One. 2014 Aug 25;9(8):e104178. doi: 10.1371/journal.pone.0104178. eCollection 2014.


Sample size considerations in the design of cluster randomized trials of combination HIV prevention.

Wang R, Goyal R, Lei Q, Essex M, De Gruttola V.

Clin Trials. 2014 Jun;11(3):309-318. doi: 10.1177/1740774514523351.



Stephens AJ, Tchetgen Tchetgen EJ, De Gruttola V.

Ann Appl Stat. 2013 Dec 23;7(4):2106-2137.


Locally efficient estimation of marginal treatment effects when outcomes are correlated: is the prize worth the chase?

Stephens A, Tchetgen Tchetgen E, De Gruttola V.

Int J Biostat. 2014;10(1):59-75. doi: 10.1515/ijb-2013-0031.


Linkage of viral sequences among HIV-infected village residents in Botswana: estimation of linkage rates in the presence of missing data.

Carnegie NB, Wang R, Novitsky V, De Gruttola V.

PLoS Comput Biol. 2014 Jan;10(1):e1003430. doi: 10.1371/journal.pcbi.1003430. Epub 2014 Jan 9.


Changes in HIV-1 subtypes B and C genital tract RNA in women and men after initiation of antiretroviral therapy.

Fiscus SA, Cu-Uvin S, Eshete AT, Hughes MD, Bao Y, Hosseinipour M, Grinsztejn B, Badal-Faesen S, Dragavon J, Coombs RW, Braun K, Moran L, Hakim J, Flanigan T, Kumarasamy N, Campbell TB; A5185s Team.

Clin Infect Dis. 2013 Jul;57(2):290-7. doi: 10.1093/cid/cit195. Epub 2013 Mar 26.


A general implementation of TMLE for longitudinal data applied to causal inference in survival analysis.

Stitelman OM, De Gruttola V, van der Laan MJ.

Int J Biostat. 2012 Sep 18;8(1). pii: /j/ijb.2012.8.issue-1/1557-4679.1334/1557-4679.1334.xml. doi: 10.1515/1557-4679.1334.


T cell activation markers and African mitochondrial DNA haplogroups among non-Hispanic black participants in AIDS clinical trials group study 384.

Hulgan T, Robbins GK, Kalams SA, Samuels DC, Grady B, Shafer R, Murdock DG, Selph D, Haas DW, Pollard RB; AIDS Clinical Trials Group.

PLoS One. 2012;7(8):e43803. doi: 10.1371/journal.pone.0043803. Epub 2012 Aug 27.


Efficacy and safety of three antiretroviral regimens for initial treatment of HIV-1: a randomized clinical trial in diverse multinational settings.

Campbell TB, Smeaton LM, Kumarasamy N, Flanigan T, Klingman KL, Firnhaber C, Grinsztejn B, Hosseinipour MC, Kumwenda J, Lalloo U, Riviere C, Sanchez J, Melo M, Supparatpinyo K, Tripathy S, Martinez AI, Nair A, Walawander A, Moran L, Chen Y, Snowden W, Rooney JF, Uy J, Schooley RT, De Gruttola V, Hakim JG; PEARLS study team of the ACTG.

PLoS Med. 2012;9(8):e1001290. Epub 2012 Aug 14.


Using HIV transmission networks to investigate community effects in HIV prevention trials.

Wertheim JO, Kosakovsky Pond SL, Little SJ, De Gruttola V.

PLoS One. 2011;6(11):e27775. doi: 10.1371/journal.pone.0027775. Epub 2011 Nov 16.


Mitochondrial genomics and CD4 T-cell count recovery after antiretroviral therapy initiation in AIDS clinical trials group study 384.

Grady BJ, Samuels DC, Robbins GK, Selph D, Canter JA, Pollard RB, Haas DW, Shafer R, Kalams SA, Murdock DG, Ritchie MD, Hulgan T; ACTG 384 and DACS 250 Study Teams.

J Acquir Immune Defic Syndr. 2011 Dec 1;58(4):363-70. doi: 10.1097/QAI.0b013e31822c688b.


Bayesian methods for fitting mixture models that characterize branching tree processes: An application to development of resistant TB strains.

Izu A, Cohen T, Mitnick C, Murray M, De Gruttola V.

Stat Med. 2011 Sep 30;30(22):2708-20. doi: 10.1002/sim.4287. Epub 2011 Jun 30.


A comparison of the efficacy of two interventions to reduce HIV risk behaviors among drug users.

McCoy CB, De Gruttola V, Metsch L, Comerford M.

AIDS Behav. 2011 Nov;15(8):1707-14. doi: 10.1007/s10461-011-9975-1.


WHO 2010 guidelines for prevention of mother-to-child HIV transmission in Zimbabwe: modeling clinical outcomes in infants and mothers.

Ciaranello AL, Perez F, Maruva M, Chu J, Engelsmann B, Keatinge J, Walensky RP, Mushavi A, Mugwagwa R, Dabis F, Freedberg KA; CEPAC-International Investigators.

PLoS One. 2011;6(6):e20224. doi: 10.1371/journal.pone.0020224. Epub 2011 Jun 2.


Targeted maximum likelihood estimation of effect modification parameters in survival analysis.

Stitelman OM, Wester CW, De Gruttola V, van der Laan MJ.

Int J Biostat. 2011 Mar 30;7(1):19. doi: 10.2202/1557-4679.1307.


Extended high viremics: a substantial fraction of individuals maintain high plasma viral RNA levels after acute HIV-1 subtype C infection.

Novitsky V, Ndung'u T, Wang R, Bussmann H, Chonco F, Makhema J, De Gruttola V, Walker BD, Essex M.

AIDS. 2011 Jul 31;25(12):1515-22. doi: 10.1097/QAD.0b013e3283471eb2.


First-line antiretroviral therapy after single-dose nevirapine exposure in South Africa: a cost-effectiveness analysis of the OCTANE trial.

Ciaranello AL, Lockman S, Freedberg KA, Hughes M, Chu J, Currier J, Wood R, Holmes CB, Pillay S, Conradie F, McIntyre J, Losina E, Walensky RP; CEPAC-International and OCTANE Investigators.

AIDS. 2011 Feb 20;25(4):479-92. doi: 10.1097/QAD.0b013e3283428cbe.


Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas.

Firnhaber C, Smeaton L, Saukila N, Flanigan T, Gangakhedkar R, Kumwenda J, La Rosa A, Kumarasamy N, De Gruttola V, Hakim JG, Campbell TB.

Int J Infect Dis. 2010 Dec;14(12):e1088-92. doi: 10.1016/j.ijid.2010.08.002. Epub 2010 Oct 18.


First-event or marginal estimation of cause-specific hazards for analysing correlated multivariate failure-time data?

Tai BC, De Stavola BL, de Gruttola V, Gebski V, Machin D.

Stat Med. 2008 Mar 15;27(6):922-36.


Drug development strategies for salvage therapy: conflicts and solutions.

De Gruttola V, Flexner C, Schapiro J, Hughes M, Van Der Laan M, Kuritzkes DR.

AIDS Res Hum Retroviruses. 2006 Nov;22(11):1106-9. No abstract available.


Validation and discovery in Markov models of genetics data.

De Gruttola V, Foulkes AS.

Stat Appl Genet Mol Biol. 2004;3:Article38. Epub 2004 Dec 27.


Pharmacogenetics of long-term responses to antiretroviral regimens containing Efavirenz and/or Nelfinavir: an Adult Aids Clinical Trials Group Study.

Haas DW, Smeaton LM, Shafer RW, Robbins GK, Morse GD, Labbe L, Wilkinson GR, Clifford DB, D'Aquila RT, De Gruttola V, Pollard RB, Merigan TC, Hirsch MS, George AL Jr, Donahue JP, Kim RB.

J Infect Dis. 2005 Dec 1;192(11):1931-42. Epub 2005 Nov 1.


Sexual behavior patterns and HIV risks in bisexual men compared to exclusively heterosexual and homosexual men.

Izazola-Licea JA, Gortmaker SL, de Gruttola V, Tolbert K, Mann J.

Salud Publica Mex. 2003;45 Supp 5:S662-71.


Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection.

Shafer RW, Smeaton LM, Robbins GK, De Gruttola V, Snyder SW, D'Aquila RT, Johnson VA, Morse GD, Nokta MA, Martinez AI, Gripshover BM, Kaul P, Haubrich R, Swingle M, McCarty SD, Vella S, Hirsch MS, Merigan TC; AIDS Clinical Trials Group 384 Team.

N Engl J Med. 2003 Dec 11;349(24):2304-15.


Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection.

Robbins GK, De Gruttola V, Shafer RW, Smeaton LM, Snyder SW, Pettinelli C, Dubé MP, Fischl MA, Pollard RB, Delapenha R, Gedeon L, van der Horst C, Murphy RL, Becker MI, D'Aquila RT, Vella S, Merigan TC, Hirsch MS; AIDS Clinical Trials Group 384 Team.

N Engl J Med. 2003 Dec 11;349(24):2293-303.


Cytomegalovirus (CMV) polymerase chain reaction profiles in individuals with advanced human immunodeficiency virus infection: relationship to CMV disease.

Nokta MA, Holland F, De Gruttola V, Emery VC, Jacobson MA, Griffiths P, Pollard RB, Feinberg JE; AIDS Clinical Trials Group, Protocol 204/GlaxoWellcome 123-014, International CMV Prophylaxis Study Group.

J Infect Dis. 2002 Jun 15;185(12):1717-22. Epub 2002 May 31.


Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL.

Control Clin Trials. 2001 Oct;22(5):485-502.


Patterns of plasma human immunodeficiency virus type 1 RNA response to antiretroviral therapy.

Huang W, De Gruttola V, Fischl M, Hammer S, Richman D, Havlir D, Gulick R, Squires K, Mellors J.

J Infect Dis. 2001 May 15;183(10):1455-65. Epub 2001 Apr 24.


Comparative analysis of HIV type 1 genotypic resistance across antiretroviral trial treatment regimens.

Gilbert PB, Hanna GJ, De Gruttola V, Martinez-Picado J, Kuritzkes DR, Johnson VA, Richman DD, D'Aquila RT.

AIDS Res Hum Retroviruses. 2000 Sep 20;16(14):1325-36.


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