One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis.


Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
14 03 2019
Historique:
entrez: 14 3 2019
pubmed: 14 3 2019
medline: 26 3 2019
Statut: ppublish

Résumé

Tuberculosis is the leading killer of patients with human immunodeficiency virus (HIV) infection. Preventive therapy is effective, but current regimens are limited by poor implementation and low completion rates. We conducted a randomized, open-label, phase 3 noninferiority trial comparing the efficacy and safety of a 1-month regimen of daily rifapentine plus isoniazid (1-month group) with 9 months of isoniazid alone (9-month group) in HIV-infected patients who were living in areas of high tuberculosis prevalence or who had evidence of latent tuberculosis infection. The primary end point was the first diagnosis of tuberculosis or death from tuberculosis or an unknown cause. Noninferiority would be shown if the upper limit of the 95% confidence interval for the between-group difference in the number of events per 100 person-years was less than 1.25. A total of 3000 patients were enrolled and followed for a median of 3.3 years. Of these patients, 54% were women; the median CD4+ count was 470 cells per cubic millimeter, and half the patients were receiving antiretroviral therapy. The primary end point was reported in 32 of 1488 patients (2%) in the 1-month group and in 33 of 1498 (2%) in the 9-month group, for an incidence rate of 0.65 per 100 person-years and 0.67 per 100 person-years, respectively (rate difference in the 1-month group, -0.02 per 100 person-years; upper limit of the 95% confidence interval, 0.30). Serious adverse events occurred in 6% of the patients in the 1-month group and in 7% of those in the 9-month group (P = 0.07). The percentage of treatment completion was significantly higher in the 1-month group than in the 9-month group (97% vs. 90%, P<0.001). A 1-month regimen of rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing tuberculosis in HIV-infected patients. The percentage of patients who completed treatment was significantly higher in the 1-month group. (Funded by the National Institute of Allergy and Infectious Diseases; BRIEF TB/A5279 ClinicalTrials.gov number, NCT01404312.).

Sections du résumé

BACKGROUND
Tuberculosis is the leading killer of patients with human immunodeficiency virus (HIV) infection. Preventive therapy is effective, but current regimens are limited by poor implementation and low completion rates.
METHODS
We conducted a randomized, open-label, phase 3 noninferiority trial comparing the efficacy and safety of a 1-month regimen of daily rifapentine plus isoniazid (1-month group) with 9 months of isoniazid alone (9-month group) in HIV-infected patients who were living in areas of high tuberculosis prevalence or who had evidence of latent tuberculosis infection. The primary end point was the first diagnosis of tuberculosis or death from tuberculosis or an unknown cause. Noninferiority would be shown if the upper limit of the 95% confidence interval for the between-group difference in the number of events per 100 person-years was less than 1.25.
RESULTS
A total of 3000 patients were enrolled and followed for a median of 3.3 years. Of these patients, 54% were women; the median CD4+ count was 470 cells per cubic millimeter, and half the patients were receiving antiretroviral therapy. The primary end point was reported in 32 of 1488 patients (2%) in the 1-month group and in 33 of 1498 (2%) in the 9-month group, for an incidence rate of 0.65 per 100 person-years and 0.67 per 100 person-years, respectively (rate difference in the 1-month group, -0.02 per 100 person-years; upper limit of the 95% confidence interval, 0.30). Serious adverse events occurred in 6% of the patients in the 1-month group and in 7% of those in the 9-month group (P = 0.07). The percentage of treatment completion was significantly higher in the 1-month group than in the 9-month group (97% vs. 90%, P<0.001).
CONCLUSIONS
A 1-month regimen of rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing tuberculosis in HIV-infected patients. The percentage of patients who completed treatment was significantly higher in the 1-month group. (Funded by the National Institute of Allergy and Infectious Diseases; BRIEF TB/A5279 ClinicalTrials.gov number, NCT01404312.).

Identifiants

pubmed: 30865794
doi: 10.1056/NEJMoa1806808
pmc: PMC6563914
mid: NIHMS1529630
doi:

Substances chimiques

Antitubercular Agents 0
Isoniazid V83O1VOZ8L
Rifampin VJT6J7R4TR
rifapentine XJM390A33U

Banques de données

ClinicalTrials.gov
['NCT01404312']

Types de publication

Clinical Trial, Phase III Comparative Study Equivalence Trial Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

1001-1011

Subventions

Organisme : NIAID NIH HHS
ID : UM1 AI069423
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069456
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI094189
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069463
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068634
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069481
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069399
Pays : United States
Organisme : FIC NIH HHS
ID : D43 TW010062
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069463
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI106701
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI108568
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069436
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069436
Pays : United States
Organisme : NIH HHS
ID : HHSN-275201300003C
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068636
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069418
Pays : United States

Investigateurs

Sharlaa Badal-Faesen (S)
Mohammed Rassool (M)
Patricia Segura (P)
Fanny Rosas (F)
Carmela Ganoza (C)
Jessica Rios (J)
Unoda Chakalisa (U)
Mpho S Raesi (MS)
Lesedi Tirelo (L)
Moakanyi Ramogodiri (M)
Lerato Mohapi (L)
Debra Peters (D)
Lidiane de Oliveira Tuler (L)
Jessica Calazans (J)
Patcharaphan Sugandhavesa (P)
Nantisa Chotirosniramit (N)
Sajeeda Mawlana (S)
Rejoice Mosia (R)
Felluna Chauwa (F)
Godwin Ulaya (G)
Patrice Sévère (P)
Sandy Nérette (S)
James Hakim (J)
Cecilia Kanyama (C)
Charity Potani (C)
Deborah Langat (D)
Josphat Kosgei (J)
Agnes M Nzioka (AM)
Priscilla C Cheruiyot (PC)
Elisha Okeyo (E)
Prisca Rabuogi (P)
Luiz Felipe de Souza Moreira (LF)
Ivete Martins Gomesc (I)
Breno Riegel Santos (B)
Rita de Cassia Alves Lira (R)
Kiat Ruxrungtham (K)
Anchalee Avihingsanon (A)
Roger Bedimo (R)
Jennifer Klein (J)
Fred R Sattler (FR)
Frances Canchola (F)
Cathi Basler (C)
Graham Ray (G)
Roberto C Arduino (RC)
Aristoteles E Villamil (AE)
Jerrold Ellner (J)
Betsy Adams (B)
David L Cohn (DL)
Christie Lynn Costanza (CL)
Shazia Chatha (S)
Stephen A Spector (SA)
Lisa Stangl (L)
Annie Luetkemeyer (A)
Jay Dwyer (J)
Margaret A Fischl (MA)
Hector Bolivar (H)
Nina Lambert (N)
Johnny Perez (J)
Michael Yin (M)
Magdalena Sobieszczyk (M)
Shelia Dunaway (S)
Sheryl Storey (S)
Susan Pedersen (S)
Jonathan Oakes (J)
Jason E Stout (JE)
Jacquelin Granholm (J)
Norman Markowitz (N)
Linda Makohon (L)
John Baxter (J)
Pola De La Torre (P)
Rodrigo Carvalho Santana (R)
Marisa M Mussi-Pinhata (MM)
Ruben Lopez (R)
Eric Daar (E)
Jill Kunkel (J)
DeeDee Pacheco (D)

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2019 Massachusetts Medical Society.

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Auteurs

Susan Swindells (S)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Ritesh Ramchandani (R)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Amita Gupta (A)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Constance A Benson (CA)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Jorge Leon-Cruz (J)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Noluthando Mwelase (N)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Marc A Jean Juste (MA)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Javier R Lama (JR)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Javier Valencia (J)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Ayotunde Omoz-Oarhe (A)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Khuanchai Supparatpinyo (K)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Gaerolwe Masheto (G)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Lerato Mohapi (L)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Rodrigo O da Silva Escada (RO)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Sajeeda Mawlana (S)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Peter Banda (P)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Patrice Severe (P)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

James Hakim (J)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Cecilia Kanyama (C)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Deborah Langat (D)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Laura Moran (L)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Janet Andersen (J)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Courtney V Fletcher (CV)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Eric Nuermberger (E)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

Richard E Chaisson (RE)

From the University of Nebraska Medical Center, Omaha (S.S., C.V.F.); Harvard T.H. Chan School of Public Health, Boston (R.R., J.L.-C., J.A.); Johns Hopkins University School of Medicine, Baltimore (A.G., E.N., R.E.C.), and Social and Scientific Systems, Silver Spring (L. Moran) - both in Maryland; University of California, San Diego, School of Medicine, La Jolla (C.A.B.); GHESKIO, Port-au-Prince, Haiti (M.A.J.J., P.S.); Asociación Civil Impacta Salud y Educación, Lima, Peru (J.R.L., J.V.); Botswana-Harvard AIDS Partnership, Gaborone, Botswana (A.O.-O., G.M.); Chiang Mai University, Chiang Mai, Thailand (K.S.); Helen Joseph Hospital, Johannesburg (N.M.), Perinatal HIV Research Unit, Soweto (L. Mohapi), and the University of Kwa-Zulu Natal, Durban (S.M.) - all in South Africa; Instituto de Pesquisa Clínica Evandro Chagas, Rio de Janeiro (R.O.S.E.); Johns Hopkins-Blantyre Clinical Trials Unit, Blantyre (P.B.), and the University of North Carolina-Lilongwe Clinical Research Site, Lilongwe (C.K.) - both in Malawi; the University of Zimbabwe, Harare (J.H.); and Kenya Medical Research Institute-Walter Reed Clinical Research Site, Nairobi (D.L.).

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