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Volumn 62, Issue 6, 2015, Pages 761-769

Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements from an International Expert Panel

(26)  Gupta, Amita a   Mathad, Jyoti S h   Abdel Rahman, Susan M i   Albano, Jessica D j   Botgros, Radu r   Brown, Vikki k   Browning, Renee S c   Dawson, Liza c   Dooley, Kelly E b   Gnanashanmugam, Devasena c   Grinsztejn, Beatriz s   Hernandez DIaz, Sonia m   Jean Philippe, Patrick d   Kim, Peter c   Lyerly, Anne D l   Mirochnick, Mark o   Mofenson, Lynne M e   Montepiedra, Grace n   Piper, Jeanna c   Sahin, Leyla g   more..


Author keywords

Clinical trials; Latent tuberculosis infection; MDR tuberculosis; Pregnancy; Tuberculosis

Indexed keywords

NEW DRUG; TUBERCULOSTATIC AGENT;

EID: 84960129843     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ991     Document Type: Review
Times cited : (45)

References (63)
  • 1
    • 84935892144 scopus 로고    scopus 로고
    • World Health Organization. Accessed 2 December
    • World Health Organization. Global tuberculosis report 2015. Available at: http://www.who.int/tb/publications/global-report/en/. Accessed 2 December 2015.
    • (2015) Global Tuberculosis Report 2015
  • 2
    • 84918805168 scopus 로고    scopus 로고
    • Tuberculosis in pregnancy: An estimate of the global burden of disease
    • Sugarman J, Colvin C, Moran AC, Oxlade O. Tuberculosis in pregnancy: an estimate of the global burden of disease. Lancet Glob Health 2014; 2:e710-6.
    • (2014) Lancet Glob Health , vol.2 , pp. e710-e716
    • Sugarman, J.1    Colvin, C.2    Moran, A.C.3    Oxlade, O.4
  • 3
    • 84918822868 scopus 로고    scopus 로고
    • The neglected global burden of tuberculosis in pregnancy
    • Zumla A, Bates M, Mwaba P. The neglected global burden of tuberculosis in pregnancy. Lancet Glob Health 2014; 2:e675-6.
    • (2014) Lancet Glob Health , vol.2 , pp. e675-e676
    • Zumla, A.1    Bates, M.2    Mwaba, P.3
  • 4
    • 84869030511 scopus 로고    scopus 로고
    • Tuberculosis in pregnant and postpartum women: Epidemiology, management, and research gaps
    • Mathad JS, Gupta A. Tuberculosis in pregnant and postpartum women: epidemiology, management, and research gaps. Clin Infect Dis 2012; 55:1532-49.
    • (2012) Clin Infect Dis , vol.55 , pp. 1532-1549
    • Mathad, J.S.1    Gupta, A.2
  • 5
    • 76049083969 scopus 로고    scopus 로고
    • Tuberculosis in association with HIV/AIDS emerges as a major nonobstetric cause of maternal mortality in Sub-Saharan Africa
    • Grange J, Adhikari M, Ahmed Y, et al. Tuberculosis in association with HIV/AIDS emerges as a major nonobstetric cause of maternal mortality in Sub-Saharan Africa. Int J Gynaecol Obstet 2010; 108:181-3.
    • (2010) Int J Gynaecol Obstet , vol.108 , pp. 181-183
    • Grange, J.1    Adhikari, M.2    Ahmed, Y.3
  • 6
    • 1442348475 scopus 로고    scopus 로고
    • Perinatal tuberculosis and HIV-1: Considerations for resource-limited settings
    • Pillay T, Khan M, Moodley J, Adhikari M, Coovadia H. Perinatal tuberculosis and HIV-1: considerations for resource-limited settings. Lancet Infect Dis 2004; 4:155-65.
    • (2004) Lancet Infect Dis , vol.4 , pp. 155-165
    • Pillay, T.1    Khan, M.2    Moodley, J.3    Adhikari, M.4    Coovadia, H.5
  • 7
    • 84869202569 scopus 로고    scopus 로고
    • Tuberculosis in pregnancy: The challenges for South Asian countries
    • Jana N, Barik S, Arora N, Singh AK. Tuberculosis in pregnancy: the challenges for South Asian countries. J Obstet Gynaecol Res 2012; 38:1125-36.
    • (2012) J Obstet Gynaecol Res , vol.38 , pp. 1125-1136
    • Jana, N.1    Barik, S.2    Arora, N.3    Singh, A.K.4
  • 8
    • 84880727987 scopus 로고    scopus 로고
    • An analysis of pregnancy-related mortality in the KEMRI/CDC health and demographic surveillance system in western Kenya
    • Desai M, Phillips-Howard PA, Odhiambo FO, et al. An analysis of pregnancy-related mortality in the KEMRI/CDC health and demographic surveillance system in western Kenya. PLoS One 2013; 8:e68733.
    • (2013) PLoS One , vol.8 , pp. e68733
    • Desai, M.1    Phillips-Howard, P.A.2    Odhiambo, F.O.3
  • 9
    • 0032795039 scopus 로고    scopus 로고
    • A study of maternal mortality at the University Teaching Hospital, Lusaka, Zambia: The emergence of tuberculosis as a major non-obstetric cause of maternal death
    • Ahmed Y, Mwaba P, Chintu C, Grange JM, Ustianowski A, Zumla A. A study of maternal mortality at the University Teaching Hospital, Lusaka, Zambia: the emergence of tuberculosis as a major non-obstetric cause of maternal death. Int J Tuberc Lung Dis 1999; 3:675-80.
    • (1999) Int J Tuberc Lung Dis , vol.3 , pp. 675-680
    • Ahmed, Y.1    Mwaba, P.2    Chintu, C.3    Grange, J.M.4    Ustianowski, A.5    Zumla, A.6
  • 10
    • 84857130686 scopus 로고    scopus 로고
    • Risk of tuberculosis in pregnancy: A national, primary care-based cohort and self-controlled case series study
    • Zenner D, Kruijshaar ME, Andrews N, Abubakar I. Risk of tuberculosis in pregnancy: a national, primary care-based cohort and self-controlled case series study. Am J Respir Crit Care Med 2012; 185:779-84.
    • (2012) Am J Respir Crit Care Med , vol.185 , pp. 779-784
    • Zenner, D.1    Kruijshaar, M.E.2    Andrews, N.3    Abubakar, I.4
  • 12
    • 0034967831 scopus 로고    scopus 로고
    • Physiologic changes in pregnancy and their effect on drug disposition
    • Frederiksen MC. Physiologic changes in pregnancy and their effect on drug disposition. Semin Perinatol 2001; 25:120-3.
    • (2001) Semin Perinatol , vol.25 , pp. 120-123
    • Frederiksen, M.C.1
  • 13
    • 25144516296 scopus 로고    scopus 로고
    • Pregnancy-induced changes in pharmacokinetics: A mechanisticbased approach
    • Anderson GD. Pregnancy-induced changes in pharmacokinetics: a mechanisticbased approach. Clin Pharmacokinet 2005; 44:989-1008.
    • (2005) Clin Pharmacokinet , vol.44 , pp. 989-1008
    • Anderson, G.D.1
  • 14
    • 84928412745 scopus 로고    scopus 로고
    • Food and Drug Administration. Accessed 10 April
    • Food and Drug Administration. Pregnancy and lactation labeling final rule. Available at: http://1.usa.gov/1CpyUFt. Accessed 10 April 2015.
    • (2015) Pregnancy and Lactation Labeling Final Rule
  • 15
    • 0026356855 scopus 로고
    • Comparison of organ-specific toxicity of temafloxacin in animals and humans
    • Krasula RW, Pernet AG. Comparison of organ-specific toxicity of temafloxacin in animals and humans. Am J Med 1991; 91:38s-41.
    • (1991) Am J Med , vol.91 , pp. 38s-41
    • Krasula, R.W.1    Pernet, A.G.2
  • 16
  • 17
    • 0038754371 scopus 로고    scopus 로고
    • Food and Drug Administration. Accessed 13 March 2014
    • Food and Drug Administration. Guidance for industry: establishing pregnancy exposure registries. 2002. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071639.pdf. Accessed 13 March 2014.
    • (2002) Guidance for Industry: Establishing Pregnancy Exposure Registries
  • 18
    • 70349638608 scopus 로고    scopus 로고
    • World Health Organization. Geneva, Switzerland: World Health Organization
    • World Health Organization. Treatment of tuberculosis: guidelines. Geneva, Switzerland: World Health Organization; 2010.
    • (2010) Treatment of Tuberculosis: Guidelines
  • 19
    • 0037871813 scopus 로고    scopus 로고
    • Treatment of tuberculosis
    • Centers for Disease Control and Prevention
    • Centers for Disease Control and Prevention. Treatment of tuberculosis. MMWR Recomm Rep 2003; 52(RR-11):1-77.
    • (2003) MMWR Recomm Rep , vol.52 , Issue.RR-11 , pp. 1-77
  • 20
    • 84881054209 scopus 로고    scopus 로고
    • Should pyrazinamide be preferred in tuberculosis treatment during pregnancy?
    • Karabay O, Gozdas HT. Should pyrazinamide be preferred in tuberculosis treatment during pregnancy? Indian J Med Res 2013; 138:147.
    • (2013) Indian J Med Res , vol.138 , pp. 147
    • Karabay, O.1    Gozdas, H.T.2
  • 21
    • 0035964690 scopus 로고    scopus 로고
    • Maternal mortality associated with tuberculosis-HIV-1 co-infection in Durban, South Africa
    • Khan M, Pillay T, Moodley JM, Connolly CA. Maternal mortality associated with tuberculosis-HIV-1 co-infection in Durban, South Africa. AIDS 2001; 15:1857-63.
    • (2001) AIDS , vol.15 , pp. 1857-1863
    • Khan, M.1    Pillay, T.2    Moodley, J.M.3    Connolly, C.A.4
  • 22
    • 84866063828 scopus 로고    scopus 로고
    • Tuberculosis in pregnancy: A review
    • Loto OM, Awowole I. Tuberculosis in pregnancy: a review. J Pregnancy 2012; 2012:379271.
    • (2012) J Pregnancy , vol.2012 , pp. 379271
    • Loto, O.M.1    Awowole, I.2
  • 23
    • 84867746581 scopus 로고    scopus 로고
    • Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: A systematic review and meta-analysis
    • Nachega JB, Uthman OA, Anderson J, et al. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS 2012; 26:2039-52.
    • (2012) AIDS , vol.26 , pp. 2039-2052
    • Nachega, J.B.1    Uthman, O.A.2    Anderson, J.3
  • 24
    • 84874771403 scopus 로고    scopus 로고
    • Adherence with drug therapy in pregnancy
    • Matsui D. Adherence with drug therapy in pregnancy. Obstet Gynecol Int 2012; 2012:796590.
    • (2012) Obstet Gynecol Int , vol.2012 , pp. 796590
    • Matsui, D.1
  • 25
    • 84922576048 scopus 로고    scopus 로고
    • Pharmacokinetics of efavirenz and treatment of HIV-1 among pregnant women with and without tuberculosis coinfection
    • Dooley KE, Denti P, Martinson N, et al. Pharmacokinetics of efavirenz and treatment of HIV-1 among pregnant women with and without tuberculosis coinfection. J Infect Dis 2015; 211:197-205.
    • (2015) J Infect Dis , vol.211 , pp. 197-205
    • Dooley, K.E.1    Denti, P.2    Martinson, N.3
  • 29
    • 84875424497 scopus 로고    scopus 로고
    • Pregnancy outcomes in HIVinfected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy
    • Taylor AW, Mosimaneotsile B, Mathebula U, et al. Pregnancy outcomes in HIVinfected women receiving long-term isoniazid prophylaxis for tuberculosis and antiretroviral therapy. Infect Dis Obstet Gynecol 2013; doi:10.1155/2013/195637.
    • (2013) Infect Dis Obstet Gynecol
    • Taylor, A.W.1    Mosimaneotsile, B.2    Mathebula, U.3
  • 30
    • 83155182847 scopus 로고    scopus 로고
    • Three months of rifapentine and isoniazid for latent tuberculosis infection
    • Sterling TR, Villarino ME, Borisov AS, et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med 2011; 365:2155-66.
    • (2011) N Engl J Med , vol.365 , pp. 2155-2166
    • Sterling, T.R.1    Villarino, M.E.2    Borisov, A.S.3
  • 31
    • 79960101197 scopus 로고    scopus 로고
    • New regimens to prevent tuberculosis in adults with HIV infection
    • Martinson NA, Barnes GL, Moulton LH, et al. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med 2011; 365:11-20.
    • (2011) N Engl J Med , vol.365 , pp. 11-20
    • Martinson, N.A.1    Barnes, G.L.2    Moulton, L.H.3
  • 32
    • 84899092782 scopus 로고    scopus 로고
    • Pregnancy differentially impacts performance of latent tuberculosis diagnostics in a high-burden setting
    • Mathad JS, Bhosale R, Sangar V, et al. Pregnancy differentially impacts performance of latent tuberculosis diagnostics in a high-burden setting. PLoS One 2014; 9:e92308.
    • (2014) PLoS One , vol.9 , pp. e92308
    • Mathad, J.S.1    Bhosale, R.2    Sangar, V.3
  • 33
    • 84906066590 scopus 로고    scopus 로고
    • Preventing tuberculosis among HIV-infected pregnant women in Lesotho: The case for rolling out active case finDing and isoniazid preventive therapy
    • Tiam A, Machekano R, Gounder CR, et al. Preventing tuberculosis among HIV-infected pregnant women in Lesotho: the case for rolling out active case finDing and isoniazid preventive therapy. J Acquir Immune Defic Syndr 2014; 67: e5-11.
    • (2014) J Acquir Immune Defic Syndr , vol.67 , pp. e5-11
    • Tiam, A.1    Machekano, R.2    Gounder, C.R.3
  • 34
    • 84884599510 scopus 로고    scopus 로고
    • Integrating tuberculosis services into a PMTCT HIV programme in South Africa
    • Searle C, Coovadia H. Integrating tuberculosis services into a PMTCT HIV programme in South Africa. Int J Tuberc Lung Dis 2013; 17:1247.
    • (2013) Int J Tuberc Lung Dis , vol.17 , pp. 1247
    • Searle, C.1    Coovadia, H.2
  • 35
    • 84884631996 scopus 로고    scopus 로고
    • Integration of tuberculosis and prevention of mother-tochild transmission of HIV programmes in South Africa
    • Uwimana J, Jackson D. Integration of tuberculosis and prevention of mother-tochild transmission of HIV programmes in South Africa. Int J Tuberc Lung Dis 2013; 17:1285-90.
    • (2013) Int J Tuberc Lung Dis , vol.17 , pp. 1285-1290
    • Uwimana, J.1    Jackson, D.2
  • 36
    • 84936941945 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic drug interactions between antiretrovirals and oral contraceptives
    • Tittle V, Bull L, Boffito M, Nwokolo N. Pharmacokinetic and pharmacodynamic drug interactions between antiretrovirals and oral contraceptives. Clin Pharmacokinet 2015; 54:23-34.
    • (2015) Clin Pharmacokinet , vol.54 , pp. 23-34
    • Tittle, V.1    Bull, L.2    Boffito, M.3    Nwokolo, N.4
  • 38
    • 84929511425 scopus 로고    scopus 로고
    • Towards early inclusion of children in tuberculosis drugs trials: A consensus statement
    • Nachman S, Ahmed A, Amanullah F, et al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis 2015; 15:711-20.
    • (2015) Lancet Infect Dis , vol.15 , pp. 711-720
    • Nachman, S.1    Ahmed, A.2    Amanullah, F.3
  • 41
  • 42
    • 79957813507 scopus 로고    scopus 로고
    • An ethically justified framework for clinical investigation to benefit pregnant and fetal patients
    • Chervenak FA, McCullough LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth 2011; 11:39-49.
    • (2011) Am J Bioeth , vol.11 , pp. 39-49
    • Chervenak, F.A.1    McCullough, L.B.2
  • 44
    • 84960137302 scopus 로고    scopus 로고
    • Code of Federal Regulation, Title 45 Public Welfare, Department of Health and Human Services, part 46, Protection of Human Subjects, Subpart B-Additional Protections for Pregnant Women, Human fetuses and Neonates Involved in Research [volume No 66] Federal Register [Page 56779] (2001) (45 CFR 46, section 46.204). Available at:. Accessed 1 December
    • Code of Federal Regulation, Title 45 Public Welfare, Department of Health and Human Services, part 46, Protection of Human Subjects, Subpart B-Additional Protections for Pregnant Women, Human fetuses and Neonates Involved in Research [volume No 66] Federal Register [Page 56779] (2001) (45 CFR 46, section 46.204). Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed 1 December 2015.
    • (2015)
  • 46
    • 79957808796 scopus 로고    scopus 로고
    • Reframing the framework: Toward fair inclusion of pregnant women as participants in research
    • Lyerly AD, Little MO, Faden RR. Reframing the framework: toward fair inclusion of pregnant women as participants in research. Am J Bioeth 2011; 11:50-2.
    • (2011) Am J Bioeth , vol.11 , pp. 50-52
    • Lyerly, A.D.1    Little, M.O.2    Faden, R.R.3
  • 47
    • 0030092757 scopus 로고    scopus 로고
    • Harms of excluDing pregnant women from clinical research: The case of HIV-infected pregnant women
    • Kass NE, Taylor HA, King PA. Harms of excluDing pregnant women from clinical research: the case of HIV-infected pregnant women. J Law Med Ethics 1996; 24:36-46.
    • (1996) J Law Med Ethics , vol.24 , pp. 36-46
    • Kass, N.E.1    Taylor, H.A.2    King, P.A.3
  • 49
    • 84960098441 scopus 로고    scopus 로고
    • Food and Drug Administration. Accessed 3 March
    • Food and Drug Administration. Guidance for industry. Pulmonary tuberculosis: developing drugs for treatment. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm373580.pdf. Accessed 3 March 2015.
    • (2015) Guidance for Industry. Pulmonary Tuberculosis: Developing Drugs for Treatment
  • 51
    • 84960137304 scopus 로고
    • Revised policy on inclusion of women of childbearing potential in Clinical Trials
    • Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs:III. . Accessed 11 December 2015
    • Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs:III. Revised policy on inclusion of women of childbearing potential in Clinical Trials. Federal Register 1993; 58(139):39407. Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126835.pdf. Accessed 11 December 2015.
    • (1993) Federal Register , vol.58 , Issue.139 , pp. 39407
  • 52
    • 67349170349 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Accessed 12 March 2014
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling. 2008. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003307.pdf. Accessed 12 March 2014.
    • (2008) Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling
  • 53
    • 0034969045 scopus 로고    scopus 로고
    • Approaches to pharmacokinetic/pharmacodynamic modeling during pregnancy
    • Wyska E, Jusko WJ. Approaches to pharmacokinetic/pharmacodynamic modeling during pregnancy. Semin Perinatol 2001; 25:124-32.
    • (2001) Semin Perinatol , vol.25 , pp. 124-132
    • Wyska, E.1    Jusko, W.J.2
  • 55
    • 28644441537 scopus 로고    scopus 로고
    • Food and Drug Administration. Accessed 13 March 2014
    • Food and Drug Administration. Reviewer guidance: evaluating the risks of drug exposure in human pregnancies. 2005. Available at: http://www.fda.gov/downloads/scienceresearch/specialtopics/womenshealthresearch/ucm133359.pdf. Accessed 13 March 2014.
    • (2005) Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies
  • 56
    • 84979862120 scopus 로고    scopus 로고
    • Designing drug trials: Considerations for pregnant women
    • Sheffield JS SD, Mirochnick M, et al. Designing drug trials: considerations for pregnant women. Clin Infect Dis 2014; 59(suppl 7):S437-44.
    • (2014) Clin Infect Dis , vol.59 , pp. S437-S444
    • Sheffield, J.S.S.D.1    Mirochnick, M.2
  • 57
    • 84937437343 scopus 로고    scopus 로고
    • Special populations and pharmacogenetic issues in tuberculosis drug development and clinical research
    • McIlleron H, Abdel-Rahman S, Dave JA, Blockman M, Owen A. Special populations and pharmacogenetic issues in tuberculosis drug development and clinical research. J Infect Dis 2015; 211(suppl 3):S115-25.
    • (2015) J Infect Dis , vol.211 , pp. S115-S125
    • McIlleron, H.1    Abdel-Rahman, S.2    Dave, J.A.3    Blockman, M.4    Owen, A.5
  • 60
    • 53049106423 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Accessed 13 March 2014
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data. 2005. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2009/11/WC500011303.pdf. Accessed 13 March 2014.
    • (2005) Guideline on the Exposure to Medicinal Products during Pregnancy: Need for Post-authorisation Data
  • 61
    • 77953725982 scopus 로고    scopus 로고
    • Antiretroviral regimens in pregnancy and breastfeeDing in Botswana
    • Shapiro RL HM, Ogwu A, et al. Antiretroviral regimens in pregnancy and breastfeeDing in Botswana. N Engl J Med 2010; 362:2282-94.
    • (2010) N Engl J Med , vol.362 , pp. 2282-2294
    • Shapiro, R.L.H.M.1    Ogwu, A.2
  • 62
    • 77953723667 scopus 로고    scopus 로고
    • Maternal or infant antiretroviral drugs to reduce HIV-1 transmission
    • Chasela CS HM, Jamieson DJ, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med 2010; 362:2271-81.
    • (2010) N Engl J Med , vol.362 , pp. 2271-2281
    • Chasela, C.S.H.M.1    Jamieson, D.J.2
  • 63
    • 84960137305 scopus 로고    scopus 로고
    • International Maternal Pediatric Adolescent AIDS Clinical Trials Network. Studies. Accessed 1 December
    • International Maternal Pediatric Adolescent AIDS Clinical Trials Network. Studies. Available at: http://impaactnetwork.org/studies/index.asp#devel. Accessed 1 December 2015.
    • (2015)


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