Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): A randomised, double-blind, placebo-controlled trial

The Lancet

Volumn 379, Issue 9812, 2012, Pages 221-228

  Coovadia, Hoosen M ^a,b   Brown, Elizabeth R ^c   Fowler, Mary Glenn ^d   Chipato, Tsungai ^e   Moodley, Dhayendre ^f   Manji, Karim ^g   Musoke, Philippa ^h   Stranix Chibanda, Lynda ^e   Chetty, Vani ^f   Fawzi, Wafaie ⁱ   Nakabiito, Clemensia ^h   Msweli, Lindiwe ^f   Kisenge, Roderick ^g   Guay, Laura ^j   Mwatha, Anthony ^c   Lynn, Diana J ^c   Eshleman, Susan H ^d   Richardson, Paul ^d   George, Kathleen ^k   Andrew, Philip ^k   Mofenson, Lynne M ^l   Zwerski, Sheryl ^m   Maldonado, Yvonne ⁿ   more..

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b UNIVERSITY OF KWAZULU NATAL   (South Africa)

^c USA   (United States)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF ZIMBABWE   (Zimbabwe)

^f UNIVERSITY OF KWAZULU NATAL   (South Africa)

^g MUHIMBILI UNIVERSITY OF HEALTH AND ALLIED SCIENCES   (Tanzania)

^h MAKERERE UNIVERSITY   (Uganda)

ⁱ HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^j GEORGE WASHINGTON UNIVERSITY   (United States)

^k FAMILY HEALTH INTERNATIONAL   (United States)

^l EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^m NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

ⁿ STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; NEVIRAPINE; PLACEBO;

ADULT; ANEMIA; ARTICLE; BREAST FEEDING; BRONCHOPNEUMONIA; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FEMALE; GASTROENTERITIS; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INFANT; INFECTION PREVENTION; KWASHIORKOR; LONG TERM CARE; MAJOR CLINICAL STUDY; MALARIA; MALE; MATERNAL TREATMENT; MORTALITY; NEUTROPENIA; NEWBORN; PHASE 3 CLINICAL TRIAL; PNEUMONIA; POSTNATAL CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUSPENSION; TREATMENT DURATION; VIRUS TRANSMISSION;

EID: 84856080219     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(11)61653-X     Document Type: Article

References (23)

1. A Coutsoudis, F Dabis, W Fawzi the Breastfeeding and HIV International Transmission Study Group Late postnatal transmission of HIV-1 in breast-fed children: an individual patient data meta-analysis J Infect Dis 189 2004 2154 2166
2. V Leroy, JM Karon, A Alioum the West Africa PMTCT Study Group Twenty-four month efficacy of a maternal short-course zidovudine regimen to prevent mother-to-child transmission of HIV-1 in West Africa AIDS 16 2002 631 641 (Pubitemid 34218860)
3. Petra Study Team Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomised, double-blind, placebo-controlled trial Lancet 359 2002 1178 1186
4. WHO Collaborative Study Team on the Role of Breastfeeding on the Prevention of Infant Mortality Effect of breastfeeding on infant and child mortality due to infectious diseases in less developed countries: a pooled analysis Lancet 355 2000 451 455
5. A Bedri, B Gudetta, A Isehak the Six Week Extended-Dose Nevirapine (SWEN) Study Team Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials Lancet 372 2008 300 313
6. NI Kumwenda, DR Hoover, LM Mofenson et al. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission N Engl J Med 359 2008 119 129 (Pubitemid 351962035)
7. CS Chasela, MG Hudgens, DJ Jamieson the BAN Study Group Maternal or infant antiretroviral drugs to reduce HIV-1 transmission N Engl J Med 362 2010 2271 2281
8. RL Shapiro, MD Hughes, A Ogwu et al. Antiretroviral regimens in pregnancy and breast-feeding in Botswana N Engl J Med 362 2010 2282 2294
9. AL Ciaranello, JE Park, L Ramirez-Avila, KA Freedberg, RP Walensky, V Leroy Early infant HIV-1 diagnosis programs in resource-limited settings: opportunities for improved outcomes and more cost-effective interventions BMC Med 9 2011 59
10. WHO Guidelines on HIV and infant feeding 2010. Principles and recommendations for infant feeding in the context of HIV and a summary of evidence http://whqlibdoc.who.int/publications/2010/9789241599535-eng.pdf (accessed May 22, 2011).
11. WHO Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants. Recommendations for a public health approach. 2010 Version http://whqlibdoc.who.int/publications/2010/9789241599818-eng.pdf (accessed May 21, 2011).
12. PM Barker, W Mphatswe, N Rollins Antiretroviral drugs in the cupboard are not enough: the impact of health systems' performance on mother-to-child transmission of HIV J Acquir Immune Defic Syndr 56 2011 e45 e48
13. de Vincenzi I and the Kesho Bora Study Group Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 (Kesho Bora study): a randomized controlled trial Lancet Infect Dis 11 2011 171 180
14. RW Nduati, GC John, D Mbori-Ngacha et al. Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial JAMA 283 2000 1175 1182
15. D Moodley, J Moodley, H Coovadia the South African Intrapartum Nevirapine Trial (SAINT) Investigators A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1 J Infect Dis 187 2003 725 735 (Pubitemid 36286932)
16. MG Fowler, ML Newell Breast-feeding and HIV-1 transmission in resource-limited settings J Acquir Immune Defic Syndr 30 2002 230 239 (Pubitemid 34664420)
17. TE Taha, Q Li, DR Hoover et al. Post-exposure prophylaxis of breastfeeding HIV-exposed infants with antiretroviral drugs to age 14 weeks: updated efficacy results of the PEPI-Malawi Trial J Acquir Immune Defic Syndr 57 2011 319 325
18. L Kuhn, GM Aldrovandi, M Sinkala, C Kankasa, M Mwiya, DM Thea Potential impact of new WHO criteria for antiretroviral treatment for prevention of mother-to-child HIV transmission AIDS 24 2010 1374 1377
19. L Kuhn, GM Aldrovandi, M Sinkala the Zambia Exclusive Breastfeeding Study Effects of early, abrupt weaning on HIV-free survival of children in Zambia N Engl J Med 359 2008 130 141 (Pubitemid 351962036)
20. L Kuhn, GM Aldrovandi, M Sinkala the Zambia Exclusive Breastfeeding Study (ZEBS) Differential effects of early weaning for HIV-free survival of children born to HIV-infected mothers by severity of maternal disease PLoS One 4 2009 e6059
21. G Kafulafula, DR Hoover, TE Taha et al. Frequency of gastroenteritis and gastroenteritis-associated mortality with early weaning in HIV-1-uninfected children born to HIV-infected women in Malawi J Acquir Immune Defic Syndr 53 2010 6 13
22. A Medley, C Garcia-Moreno, S McGill, S Maman Rates, barriers and outcomes of HIV serostatus disclosure among women in developing countries: implications for prevention of mother-to-child transmission programmes Bull World Health Organ 82 2004 299 307 (Pubitemid 38568468)
23. Auld AF, Bolu O, Creek T, et al. Potential impact and cost-effectiveness of the 2009 "rapid advice" PMTCT guidelines - 15 resource-limited countries, 2010. XVIII International AIDS Conference; July 18-23, 2010; Vienna, Austria. Abstr WEAE0205.