Evidence map›Paper›PMID 30865794›Full record

Trial reportThe New England journal of medicine2019

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

Susan Swindells, Ritesh Ramchandani, Amita Gupta, Constance A Benson, Jorge Leon-Cruz, Noluthando Mwelase, Marc A Jean Juste, Javier R Lama, Javier Valencia, Ayotunde Omoz-Oarhe and 16 more

6 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 183 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed, 9 pooled it
31.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01404312 phase3completednot on this map

Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2017Enrolled3,000ConditionsTuberculosis, HIV InfectionsArmsRifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
NCT03934931 nacompletednot on this mapstarted 2020, after this paper: background citation

Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2025Enrolled1,656ConditionsTuberculosis, Latent Tuberculosis, HIV/AIDSArmsStreamlined weekly DOT visits, Weekly DOT visit reminders, Cost reimbursement DOT, 99DOTS, Weekly SAT dosing reminders/check-ins
NCT03988933 phase2completednot on this map

2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB: a 3-arm Randomized Trial.

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2019 to 2024Enrolled1,368ConditionsLatent TuberculosisArmsRifampin double dose, Rifampin triple dose, Rifampin standard dose
NCT04781257 unknown statusnot on this mapstarted 2021, after this paper: background citation

Early Risk Assessment in TB contactS by New Diagnostic tEsts

TypeobservationalSponsorMichael HoelscherRan2021 to 2024Enrolled2,100ConditionsTuberculosisArmsNew test candidates
NCT05411744 phase4active not recruitingnot on this mapstarted 2022, after this paper: background citation

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

TypeinterventionalSponsorRutgers, The State University of New JerseyRan2022 to 2029Enrolled25ConditionsLatent Tuberculosis, End Stage Renal Disease, Renal Transplant Candidate for Right Kidney, Renal Transplant Candidate for Left KidneyArms1 month Rifapentine, Isoniazid and Vitamin B6
NCT07668479 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Research on Evaluating Rifapentine-Based Shorter Regimens for Tuberculosis and Tuberculosis Infection Among People Living With and Without HIV in Programmatic Settings in Kazakhstan (RIFA-REAL)

TypeobservationalSponsorPublic Union "Kazakhstan Association of Phthisiopulmonologists"Ran2026 to 2027Enrolled350ConditionsTuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive
3 · Its place in the literature

Who cites it

183 citing papers in PubMed, 9 syntheses or guidelines pooled it, 362 citations in OpenAlex.

  1. Pooled it
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  6. Guideline
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  9. Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Pooled it
  10. Three Months of Weekly Rifapentine and Isoniazid Versus Four Months of Daily Rifampicin for Tuberculosis Infection: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
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  16. Twice-Daily Dolutegravir-Based Antiretroviral Therapy With 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis Prevention.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
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  20. A Randomized Controlled Trial of Isoniazid to Prevent Mycobacterium tuberculosis Infection in Kenyan Human Immunodeficiency Virus-Exposed Uninfected Infants.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Trial

123 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 16 institutions in 10 countries.

Susan SwindellsFrom 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 RamchandaniFrom 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 GuptaFrom 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 BensonFrom 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-CruzFrom 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 MwelaseFrom 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 JusteFrom 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 LamaFrom 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 ValenciaFrom 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-OarheFrom 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 SupparatpinyoFrom 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 MashetoFrom 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 MohapiFrom 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 EscadaFrom 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 MawlanaFrom 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 BandaFrom 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 SevereFrom 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 HakimFrom 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 KanyamaFrom 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 LangatFrom 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 MoranFrom 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 AndersenFrom 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 FletcherFrom 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 NuermbergerFrom 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 ChaissonFrom 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.).
BRIEF TB/A5279 Study Team
Harvard University · USJohns Hopkins University · USAsociación Civil Impacta Salud y Educación · PEBotswana Harvard AIDS Institute Partnership · BWGheskio Centers · HTUniversity of Nebraska Medical Center · USBlantyre Institute for Community Ophthalmology · MWChiang Mai University · THHelen Joseph Hospital · ZAInstituto Evandro Chagas · BRKenya Medical Research Institute · KEPerinatal HIV Research Unit · ZASocial and Scientific Systems (United States) · USUniversity of California, San Diego · USUniversity of KwaZulu-Natal · ZAUniversity of Zimbabwe · ZW

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Moises Arturo Huaman Joo, Colleen F Kelley · 2012 to 2026
$46.0M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
Thailand HIV/AIDS and Infectious Disease Clinical Trials Unit (THAI CTU)UM1AI069399 · NIAID · CHIANG MAI UNIVERSITY · PI Kiat Ruxrungtham, Khuanchai Supparatpinyo · 2012 to 2026
$25.0M
FIC NIH HHS D43 TW010062NIAID NIH HHS P30 AI094189NIAID NIH HHS U01 AI069436NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI108568NIH HHS HHSN-275201300003C
6 · The paper itself

Abstract

backgroundTuberculosis 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.

methodsWe 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.

resultsA 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).

conclusionsA 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.).

Indexed as

AdultAIDS-Related Opportunistic InfectionsAntitubercular AgentsCD4 Lymphocyte CountDrug Administration ScheduleDrug Therapy, CombinationFemaleHIV InfectionsHumansIsoniazidLatent TuberculosisMaleMedication AdherenceRifampinTuberculosisAntitubercular AgentsIsoniazidRifampinrifapentine

Identifiers

PMID30865794
PMCPMC6563914
OpenAlexW2921307586

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.