Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand

New England Journal of Medicine

Volumn 351, Issue 3, 2004, Pages 217-228+311

  Lallemant, Marc ^a,b,i   Jourdain, Gonzague ^a,b   Le Coeur, Sophie ^a,c   Mary, Jean Yves ^d   Ngo Giang Huong, Nicole ^a,b   Koetsawang, Suporn ^e   Kanshana, Siripon ^f   McIntosh, Kenneth ^g,h   Thaineua, Vallop ^f  

^a INSTITUT DE RECHERCHE POUR LE DÉVELOPPEMENT   (France)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c INSTITUT NATIONAL D'ÉTUDES DÉMOGRAPHIQUES   (France)

^d INSERM   (France)

^e MAHIDOL UNIVERSITY   (Thailand)

^f MINISTRY OF PUBLIC HEALTH   (Thailand)

^g BOSTON CHILDREN S HOSPITAL   (United States)

^h HARVARD MEDICAL SCHOOL   (United States)

ⁱ Institute of research for development Thailand   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

NEVIRAPINE; ZIDOVUDINE; ANTIRETROVIRUS AGENT; VIRUS RNA;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFANT; KAPLAN MEIER METHOD; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RASH; RISK FACTOR; T LYMPHOCYTE; THIRD TRIMESTER PREGNANCY; VERTICAL TRANSMISSION; VIRUS LOAD; BLOOD; CD4 LYMPHOCYTE COUNT; DISEASE TRANSMISSION; DRUG COMBINATION; FOLLOW UP; GENETICS; GESTATIONAL AGE; HUMAN IMMUNODEFICIENCY VIRUS 1; LABOR; MALE; MULTICENTER STUDY; NEWBORN; PREGNANCY; PREGNANCY COMPLICATION; PREGNANCY OUTCOME; THAILAND;

ADULT; ANTI-RETROVIRAL AGENTS; CD4 LYMPHOCYTE COUNT; DISEASE TRANSMISSION, VERTICAL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; GESTATIONAL AGE; HIV INFECTIONS; HIV-1; HUMANS; INFANT; INFANT, NEWBORN; LABOR, OBSTETRIC; MALE; NEVIRAPINE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY OUTCOME; PREGNANCY TRIMESTER, THIRD; RISK FACTORS; RNA, VIRAL; THAILAND; VIRAL LOAD; ZIDOVUDINE;

EID: 3142656082     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa033500     Document Type: Article

References (43)

1. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 1994;331:1173-80.
2. Sperling RS, Shapiro DE, Coombs RW, et al. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. N Engl J Med 1996;335:1621-9.
3. Mofenson LM, McIntyre JA. Advances and research directions in the prevention of mother-to-child HIV-1 transmission. Lancet 2000;355:2237-44.
4. Kanshana S, Thewanda D, Teeraratkul A, et al. Implementing short-course zidovudine to reduce mother-infant HIV transmission in a large pilot program in Thailand. AIDS 2000;14:1617-23.
5. Lallemant M, Jourdain G, Le Coeur S, et al. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. N Engl J Med 2000;343:982-91.
6. Amornwichet P, Teeraratkul A, Simonds RJ, et al. Preventing mother-to-child HIV transmission: the first year of Thailand's national program. JAMA 2002;288:245-8.
7. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999;354:795-802.
8. Ministry of Public Health. National guidelines for the clinical management of HIV infection in children and adults. Nonthaburi, Thailand: AIDS Division, Department of Communicable Disease Control, 2000.
9. 1999 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. MMWR Recomm Rep 1999; 48(RR-10):1-59, 61-6.
10. 1995 Revised guidelines for prophylaxis against Pneumocystis carinii pneumonia for children infected with or perinatally exposed to human immunodeficiency virus. MMWR Recomm Rep 1995;44(RR-4):1-11.
11. Revised recommendations for HIV screening of pregnant women. MMWR Recomm Rep 2001;50(RR-19):63-85.
12. Fleiss JL. Statistical methods for rates and proportions. 2nd ed. New York: John Wiley, 1981:161-5.
13. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
14. Lan KKG, DeMets DL. Changing frequency of interim analysis in sequential monitoring. Biometrics 1989;45:1017-20.
15. Ellenberg JH. Intention-to-treat analysis. In: Redmond CK, Colton T, eds. Biostatistics in clinical trials. Chichester, England: John Wiley, 2001:245-9.
16. Balasubramanian R, Lagakos SW. Estimation of the timing of perinatal transmission of HIV. Biometrics 2001;57:1048-58.
17. Mofenson LM, Lambert JS, Stiehm ER, et al. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. N Engl J Med 1999;341:385-93.
18. Shapiro DE, Sperling RS, Coombs RW. Effect of zidovudine on perinatal HIV-1 transmission and maternal viral load. Lancet 1999;354:156.
19. Wade NA, Birkhead GS, Warren BL, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339:1409-14.
20. Matheson PB, Abrams EJ, Thomas PA, et al. Efficacy of antenatal zidovudine in reducing perinatal transmission of human immunodeficiency virus type 1. J Infect Dis 1995;172:353-8.
21. Simpson BJ, Shapiro ED, Andiman WA. Reduction in the risk of vertical transmission of HIV-1 associated with treatment of pregnant women with orally administered zidovudine alone. J Acquir Immune Defic Syndr Hum Retrovirol 1997;14:145-52.
22. Guidelines for the management of prevention of mother to child transmission of HIV in Thailand: policy of prevention of mother to child transmission of HIV in Thailand. Nonthaburi, Thailand: Ministry of Public Health, Department of Health, December 2003.
23. Kanshana S, Simonds RJ. National program for preventing mother-child HIV transmission in Thailand: successful implementation and lessons learned. AIDS 2002; 16:953-9.
24. Talawat S, Dore GJ, Le Coeur S, Lallemant M. Infant feeding practices and attitudes among women with HIV infection in northern Thailand. AIDS Care 2002;14:625-31.
25. Moodley D, Moodley J, Coovadia H, et al. 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 2003;187:725-35.
26. Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA 2002;288: 189-98.
27. Jackson JB, Becker-Pergola G, Guay LA, et al. Identification of the K103N resistance mutation in Ugandan women receiving nevirapine to prevent HIV-1 vertical transmission. AIDS 2000;14:F111-F115.
28. Eshleman SH, Mracna M, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS 2001;15:1951-7.
29. Cunningham CK, Chaix ML, Rekacewicz C, et al. Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: a substudy of Pediatric AIDS Clinical Trials Group protocol 316. J Infect Dis 2002; 186:181-8.
30. Morris L, Pillay C, Chezzi C, et al. Low frequency of the V106M mutation among HIV-1 subtype C-infected pregnant women exposed to nevirapine. AIDS 2003;17:1698-700.
31. Kantor R, Lee E, Johnston E, et al. Rapid flux in non-nucleoside reverse transcriptase inhibitor resistance mutations among subtype C HIV-1-infected women after single dose nevirapine. Antiviral Ther 2003;8:S85. abstract.
32. Chaix ML, Montcho C, Ekouevi DK, et al. Genotypic resistance analysis in women who received intrapartum nevirapine associated to a short course of zidovudine to prevent perinatal HIV-1 transmission: the Ditrame Plus ANRS 1201/02 Study, Abidjan, Côte d'Ivoire. In: Proceedings of the 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004:657. abstract.
33. Chalermchokcharoenkit A, Asavapiriyanont S, Teeraratkul A, et al. Combination short-course zidovudine plus 2-dose nevirapine for prevention of mother-to-child transmission: safety, tolerance, transmission, and resistance results. In: Proceedings of the 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004:96. abstract.
34. Martinson N, Morris L, Gray G, et al. HIV resistance and transmission following single-dose nevirapine in a PMTCT cohort. In: Proceedings of the 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004:38. abstract.
35. Jourdain G, Ngo-Giang-Huong N, Le Coeur S, et al. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N Engl J Med 2004;351:229-40.
36. World Health Organization. Antiretroviral drugs and the prevention of mother-to-child transmission of HIV infection in resource-limited settings: expert consultation, Geneva, 5-6 February 2004: a summary of main points from the meeting. (Accessed June 18, 2004, at http://www.who.int/3by5/arv_pmtct/en/.)
37. Bucceri AM, Somigliana E, Matrone R, et al. Combination antiretroviral therapy in 100 HIV-1-infected pregnant women. Hum Reprod 2002;17:436-41.
38. Cooper ER, Charurat M, Mofenson L, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr 2002;29:484-94.
39. Tuomala RE, Shapiro DE, Mofenson LM, et al. Antiretroviral therapy during pregnancy and the risk of an adverse outcome. N Engl J Med 2002;346:1863-70.
40. Wimalasundera RC, Larbalestier N, Smith JH, et al. Pre-eclampsia, antiretroviral therapy, and immune reconstitution. Lancet 2002;360:1152-4.
41. Shapiro D, Tuomala R, Pollack H, et al. Mother-to-child HIV transmission risk according to antiretroviral therapy, mode of delivery, and viral load in 2895 U.S. women (PACTG 367). In: Proceedings of the 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, February 8-11, 2004:99. abstract.
42. Shepard KV. Important new safety information: clarification of risk factors for severe, life-threatening and fatal hepatotoxicity with VIRAMUNE (nevirapine). Ridgefield, Conn.: Boehringer Ingelheim Pharmaceuticals, February 2004.
43. Panel on Clinical Practices for Treatment of HIV Infection. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Washington, D.C.: Department of Health and Human Services, March 23, 2004.