Document Detail


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.
MedLine Citation:
PMID:  18657709     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was to assess whether daily nevirapine given to breastfed infants through 6 weeks of age can decrease HIV transmission via breastfeeding. METHODS: HIV-infected women breastfeeding their infants were eligible for participation. Participants were randomly assigned to receive either single-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborns after birth) or 6 week extended-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborn babies after birth plus nevirapine 5 mg daily from days 8-42 for the infant). The randomisation sequences were generated by computer at a central data coordinating centre. The primary endpoint was HIV infection at 6 months of age in infants who were HIV PCR negative at birth. Analyses were by modified intention to treat, excluding infants with missing specimens and those with indeterminate or confirmed HIV infection at birth. These studies are registered with ClinicalTrials.gov, numbers NCT00074399, NCT00061321, and NCT00639938. FINDINGS: 2024 liveborn infants randomised in the study had at least one specimen tested before 6 months of age (1047 infants in the single-dose group and 977 infants in the extended-dose group). The modified intention-to-treat population included 986 infants in the single-dose group and 901 in the extended-dose group. At 6 months, 87 children in the single-dose group and 62 in the extended-dose group were infected with HIV (relative risk 0.80, 95% CI 0.58-1.10; p=0.16). At 6 weeks of age, 54 children in the single-dose group and 25 in the extended-dose group were HIV positive (0.54, 0.34-0.85; p=0.009). 393 infants in the single-dose group and 346 in the extended-dose group experienced grade 3 or 4 serious adverse events during the study (p=0.54). INTERPRETATION: Although a 6-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at 6 weeks of age, the lack of a significant reduction in the primary endpoint-risk of HIV transmission at 6 months-suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breast milk might be more effective where access to affordable and safe replacement feeding is not yet available and where the risks of replacement feeding are high. FUNDING: US National Institutes of Health; US National Institute of Allergy and Infectious Diseases; Fogarty International Center.
Authors:
; Abubaker Bedri; Berhanu Gudetta; Abdulhamid Isehak; Solomon Kumbi; Sileshi Lulseged; Yohannes Mengistu; Arvind V Bhore; Ramesh Bhosale; Venkat Varadhrajan; Nikhil Gupte; Jayagowri Sastry; Nishi Suryavanshi; Srikanth Tripathy; Francis Mmiro; Michael Mubiru; Carolyne Onyango; Adrian Taylor; Philippa Musoke; Clemensia Nakabiito; Aida Abashawl; Rahel Adamu; Gretchen Antelman; Robert C Bollinger; Patricia Bright; Mohammad A Chaudhary; Jacqueline Coberly; Laura Guay; Mary Glenn Fowler; Amita Gupta; Elham Hassen; J Brooks Jackson; Lawrence H Moulton; Uma Nayak; Saad B Omer; Lidia Propper; Malathi Ram; Vivian Rexroad; Andrea J Ruff; Anita Shankar; Sheryl Zwerski
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  Lancet     Volume:  372     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2008 Jul 
Date Detail:
Created Date:  2008-07-28     Completed Date:  2008-08-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  300-13     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00061321;  NCT00074399;  NCT00639938
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-HIV Agents / administration & dosage,  adverse effects,  therapeutic use*
Breast Feeding / adverse effects*
Drug Administration Schedule
Ethiopia
Female
HIV Infections / etiology,  prevention & control*
Humans
India
Infant
Infant, Newborn
Male
Multicenter Studies as Topic
Nevirapine / administration & dosage,  adverse effects,  therapeutic use*
Pregnancy
Randomized Controlled Trials as Topic*
Uganda
Grant Support
ID/Acronym/Agency:
D43-TW0000/TW/FIC NIH HHS; R01AI34235/AI/NIAID NIH HHS; R01AI3857601A/AI/NIAID NIH HHS; R01AI45462/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 129618-40-2/Nevirapine
Investigator
Investigator/Affiliation:
Atlalelech Abate / ; Getnet Abebe / ; Menen Abebe / ; Hana Abera / ; Yihenew Abere / ; Lemlem Adam / ; Yaregal Adamu / ; Abdulhakim Ahmed / ; Almaz Araya / ; Daniel Assefa / ; Melkam Assefa / ; Tsegaye Awano / ; Abeba Bairu / ; Abubaker Bedri / ; Muluembet Cherinet / ; Yeshi Deriba / ; Mesfin G Ggziabher / ; Esayas Gashaw / ; Yayesh Gayim / ; Alemitu Gebrie / ; Berhanu Gudetta / ; Daniel Hailu / ; Abdulhamid Isehak / ; Tsehay K Mariam / ; Melaku Kebebe / ; Solomon Kumbi / ; Dawit Lisanework / ; Sileshi Lulseged / ; Frehiwot Melkamu / ; Wondemagegne Melkamu / ; Yohannes Mengistu / ; Tegist Nemer / ; Ekuba Seyoum / ; Bizualem Shiferaw / ; Endale Tefera / ; Mesfin Tegegne / ; Yerom Tolera / ; Eyuel Tsegaye / ; Ayenew Washelegne / ; Addissu Bekele Workneh / ; Hirut Yigzaw / ; Zewdnesh Yitayew / ; Maria Yoseph / ; Nandita Ambike / ; Vidya A Arjunwadkar / ; Aparna Atre / ; Usha Balasubramanian / ; Damodar N Balpande / ; Anita B Basavaraj / ; Anand N Bhalerao / ; Manisha Bhandarkar / ; Renu S Bharadwaj / ; Kapila E Bharucha / ; Shreepad Bhat / ; Jayanta Bhattacharya / ; Medha Bhide / ; Pushkar Bhide / ; Arvind V Bhore / ; Ramesh A Bhosale / ; Uttam T Bhosale / ; Raju Bhujbal / ; Pandurang M Bulakh / ; Shubhada C Chaudhari / ; Vaishali Chaudhari / ; Vaishali Chimanpure / ; Shreepad M Dabak / ; Subhash R Daga / ; Sachin Dalal / ; Sonali Dandage / ; Snehal Dange / ; Nilesh Dayama / ; Deepali Desai / ; Balaji Deshmukh / ; Sanjay D Deshmukh / ; Anand S Deshpande / ; Jagannath Dhadwad / ; Siddhesh Dhaygude / ; Ramkrishna K Dhongade / ; Ashwini Erande / ; Prakash S Gambhir / ; Laila Garda / ; Rahul Girme / ; Maya Gitte / ; Meghana Gunjal / ; Nikhil A Gupte / ; Shilpa Hyatnagarkar / ; Sadaf Inamdar / ; Sushma Jadhav / ; Arun V Jamkar / ; Neena Jatkar / ; Aparna Joshi / ; Uttara Joshi / ; Sangeeta Joshi / ; Abhay Kadam / ; Manisha Kadam / ; Anju S Kagal / ; Rajashree Kakani / ; Arjun L Kakrani / ; Varsha Kale / ; Reena Kamble / ; Vaibhav Kamble / ; Alka P Karmarkar / ; Sameer Khan / ; Mangesh Khandave / ; Medha M Khandekar / ; Arti Kinikar / ; Dushyant Kothari / ; Anandini Kshirsagar / ; Aruna M Kulkarni / ; Poorva Kulkarni / ; Smita Kulkarni / ; Vandana Kulkarni / ; Bharat Kusram / ; Arvind S Labhsetwar / ; Smita Lahoti / ; Shilpa Lele / ; Bharati Mahajan / ; Sudhir Malawade / ; Charu Mallik / ; Nitin Mandole / ; Gorakh Mandrupkar / ; Pravin Mantri / ; Rajani R Mellinkeri / ; Anisa Memon / ; Santosh More / ; Chandraprabha A Nagwanshi / ; Sandeep Nair / ; Pushpalata R Naphade / ; Sridevi Neeli / ; Tabassum Pangarkar / ; Ramesh S Paranjape / ; Kaushal Parekh / ; Ranjeet Patil / ; Supriya Patil / ; Sandesh Patil / ; Toby Paul / ; Mita Pawar / ; Mrudula A Phadke / ; Hemlata Pisal / ; Arpita Porecha / ; Kanchanalata Puppal / ; Manali Rahalkar / ; Sheeja Reji / ; Arun R Risbud / ; Kavita Rohankhedkar / ; Parag Rote / ; Sujatha Sahu / ; Pradeep W Sambarey / ; Jayagowri Sastry / ; Jherna Sethi / ; Aparna N Shrotri / ; Khema Sonkamble / ; Shirin Sujir / ; Snehal Suregaonkar / ; Nishi Suryavanshi / ; Savita Sutar / ; Kanta Tambe / ; Sanjay G Tambe / ; Madhuri Thakkar / ; Prasad Tondare / ; Srikanth Tripathy / ; Tasneem Tyebjee / ; Winston Umakanth / ; Shalini Umranikar / ; Vidya Upadhye / ; Venkat Varadhrajan / ; Sachin V Wankhede / ; Uma N Wankhede / ; Vishwanath L Yemul / ; Dinah Amongin / ; Danstan Bagenda / ; Gad Bihabwa / ; Christine Biryabarema / ; Ali Elbireer / ; Peace Kabagambe / ; Enid Kabugho / ; Samuel Kabwigu / ; Brenda Kakayi / ; Samuel Kalisooke / ; Betty Kamira / ; Phiona Kibalama / ; Florence Kikonyogo / ; Alice Kiwanuka / ; Irene Lubega / ; Florence Mirembe / ; Jamil Mugalu / ; Christine Mugasha / ; Sarah Mulebeke / ; Maria Musisi / ; Twaha Mutyaba / ; Evelyn Nabunya / ; Margaret Nakakeeto / ; Jessica Nakibuuka / ; Teopista Nakyanzi / ; Beatrice Namaganda / ; Constance Namirembe / ; Winnie Nansamba / ; Christopher Ndugwa / ; Natalia Nyombi / ; Susan Obore / ; Maxensia Owor / ; Rebecca Sakwa / ; Julie Walabyeki / ; Lillian Wambuzi / ; Christopher Abashawl / ; Rahel Adamu / ; Gretchen Antelman / ; Robert C Bollinger / ; Stephen Bolton / ; Patricia Bright / ; Ronald Brookmeyer / ; Mohammad A Chaudhary / ; Joline Choi / ; Victoria Chou / ; Jacqueline Coberly / ; Mary Glenn Fowler / ; Laura A Guay / ; Amita Gupta / ; Neal Halsey / ; Elham Hassen / ; J Brooks Jackson / ; Mahnaz Motevalli / ; Lawrence H Moulton / ; John Olin / ; Saad B Omer / ; Uma Nayak / ; Lidia Propper / ; Malathi Ram / ; Andrea J Ruff / ; Anita Shankar / ; Vivian Rexroad / ; Samuel Adeniyi-Jones / ; Usha Sharma / ; Lydia Soto-Torres / ; Sheryl Zwerski /
Comments/Corrections
Comment In:
Lancet. 2008 Jul 26;372(9635):267-9   [PMID:  18657690 ]
Lancet. 2008 Jul 26;372(9635):269-70   [PMID:  18657691 ]
Lancet. 2008 Jul 26;372(9635):287   [PMID:  18657698 ]

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