Daily Nevirapine to Prevent Mother to Infant Transmission of HIV (SWEN)
Prevention of Maternal to Infant HIV Transmission in India
Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV.
Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth.
This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.
調査の概要
詳細な説明
This study will evaluate the safety and effectiveness of adding daily infant NVP to standard prevention measures to decrease vertical transmission of HIV.
According to current statistics from the study site, approximately 70% of the pregnant HIV infected women in this study will have begun antenatal ZDV prior to the initiation of NVP at labor. The remaining 30% of the HIV infected women enrolled in this trial will have been previously undiagnosed. These women will be diagnosed with HIV infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for HIV screening prior to delivery.
All infants will receive the standard does of NVP at 72 hours postpartum. Infants will then be randomized to receive either daily NVP and a daily multivitamin (MVI) or a daily MVI alone. Infants will take NVP/MVI or MVI alone during Weeks 2 to 6 postpartum. The primary outcome measure is infant HIV infection rates at 6 months.
Two additional related cohorts of women will be followed for comparison: 1) an equal number of HIV uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality; and 2) consenting HIV infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort.
研究の種類
介入
入学 (実際)
770
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pune、インド
- BJ Medical College
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria for Pregnant or Postpartum Mothers
- HIV infected
- Planning to breastfeed
- Able to tolerate oral drugs and available for 12 months of postpartum follow-up
Exclusion Criteria
- Significant physical or emotional distress
- Infant with serious or life threatening disease or severe fetal abnormality
- Obstetrical complications affecting maternal health
- Prior antiretroviral drugs (except antenatal ZDV or intrapartum (NVP)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：1
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum
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Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
他の名前：
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実験的：2
Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day)by mouth, from week 1 through week 6 post-partum Infants: Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
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Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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HIV infection rate of infants
時間枠：6 months of age
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6 months of age
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Safety of the regimens for HIV-infected mothers and their breast-fed infants
時間枠：Through 12 months post-partum
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Through 12 months post-partum
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Acceptability and compliance of intervention regimens
時間枠：Until 6 weeks of age
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Until 6 weeks of age
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Time to HIV infection by treatment regimen
時間枠：over 12 months of age
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over 12 months of age
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Time to infection by infant feeding practice and time to weaning
時間枠：Until 12 months post-partum
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Until 12 months post-partum
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Maternal ZDV and NVP resistance
時間枠：Baseline and post-partum
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Baseline and post-partum
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Infant morbidity and mortality by treatment arm
時間枠：Until 12 months post partum
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Until 12 months post partum
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Infant NVP resistance by treatment arm
時間枠：Up to 12 months post partum
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Up to 12 months post partum
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Maternal NVP pharmacokinetics
時間枠：Up to 12 months post-partum
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Up to 12 months post-partum
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Infant NVP pharmacokinetics
時間枠：Up to 12 months post-partum
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Up to 12 months post-partum
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Robert C. Bollinger, MD, MPH、Johns Hopkins University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Six Week Extended-Dose Nevirapine (SWEN) Study Team; Bedri A, Gudetta B, Isehak A, Kumbi S, Lulseged S, Mengistu Y, Bhore AV, Bhosale R, Varadhrajan V, Gupte N, Sastry J, Suryavanshi N, Tripathy S, Mmiro F, Mubiru M, Onyango C, Taylor A, Musoke P, Nakabiito C, Abashawl A, Adamu R, Antelman G, Bollinger RC, Bright P, Chaudhary MA, Coberly J, Guay L, Fowler MG, Gupta A, Hassen E, Jackson JB, Moulton LH, Nayak U, Omer SB, Propper L, Ram M, Rexroad V, Ruff AJ, Shankar A, Zwerski S. 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. 2008 Jul 26;372(9635):300-13. doi: 10.1016/S0140-6736(08)61114-9.
- Shankar AV, Sastry J, Erande A, Joshi A, Suryawanshi N, Phadke MA, Bollinger RC. Making the choice: the translation of global HIV and infant feeding policy to local practice among mothers in Pune, India. J Nutr. 2005 Apr;135(4):960-5. doi: 10.1093/jn/135.4.960.
- Pisal H, Sutar S, Sastry J, Kapadia-Kundu N, Joshi A, Joshi M, Leslie J, Scotti L, Bharucha K, Suryavanshi N, Phadke M, Bollinger R, Shankar AV. Nurses' health education program in India increases HIV knowledge and reduces fear. J Assoc Nurses AIDS Care. 2007 Nov-Dec;18(6):32-43. doi: 10.1016/j.jana.2007.06.002.
- Bhore AV, Sastry J, Patke D, Gupte N, Bulakh PM, Lele S, Karmarkar A, Bharucha KE, Shrotri A, Pisal H, Suryawanshi N, Tripathy S, Risbud AR, Paranjape RS, Shankar AV, Kshirsagar A, Phadke MA, Joshi PL, Brookmeyer RS, Bollinger RC Jr. Sensitivity and specificity of rapid HIV testing of pregnant women in India. Int J STD AIDS. 2003 Jan;14(1):37-41. doi: 10.1258/095646203321043246.
- Suryavanshi N, Jonnalagadda S, Erande AS, Sastry J, Pisal H, Bharucha KE, Shrotri A, Bulakh PM, Phadke MA, Bollinger RC, Shankar AV. Infant feeding practices of HIV-positive mothers in India. J Nutr. 2003 May;133(5):1326-31. doi: 10.1093/jn/133.5.1326.
- Phadke MA, Gadgil B, Bharucha KE, Shrotri AN, Sastry J, Gupte NA, Brookmeyer R, Paranjape RS, Bulakh PM, Pisal H, Suryavanshi N, Shankar AV, Propper L, Joshi PL, Bollinger RC. Replacement-fed infants born to HIV-infected mothers in India have a high early postpartum rate of hospitalization. J Nutr. 2003 Oct;133(10):3153-7. doi: 10.1093/jn/133.10.3153.
- Shankar AV, Pisal H, Patil O, Joshi A, Suryavanshi N, Shrotri A, Bharucha KE, Bulakh P, Phadke MA, Bollinger RC, Sastry J. Women's acceptability and husband's support of rapid HIV testing of pregnant women in India. AIDS Care. 2003 Dec;15(6):871-4. doi: 10.1080/09540120310001618702.
- Shrotri A, Shankar AV, Sutar S, Joshi A, Suryawanshi N, Pisal H, Bharucha KE, Phadke MA, Bollinger RC, Sastry J. Awareness of HIV/AIDS and household environment of pregnant women in Pune, India. Int J STD AIDS. 2003 Dec;14(12):835-9. doi: 10.1258/095646203322556183.
- Sastry J, Pisal H, Sutar S, Kapadia-Kundu N, Joshi A, Suryavanshi N, Bharucha KE, Shrotri A, Phadke MA, Bollinger RC, Shankar AV. Optimizing the HIV/AIDS informed consent process in India. BMC Med. 2004 Aug 2;2:28. doi: 10.1186/1741-7015-2-28.
- Bharucha KE, Sastry J, Shrotri A, Sutar S, Joshi A, Bhore AV, Phadke MA, Bollinger RC, Shankar AV. Feasibility of voluntary counselling and testing services for HIV among pregnant women presenting in labour in Pune, India. Int J STD AIDS. 2005 Aug;16(8):553-5. doi: 10.1258/0956462054679250.
- Gupta A, Nayak U, Ram M, Bhosale R, Patil S, Basavraj A, Kakrani A, Philip S, Desai D, Sastry J, Bollinger RC; Byramjee Jeejeebhoy Medical College-Johns Hopkins University Study Group. Postpartum tuberculosis incidence and mortality among HIV-infected women and their infants in Pune, India, 2002-2005. Clin Infect Dis. 2007 Jul 15;45(2):241-9. doi: 10.1086/518974. Epub 2007 Jun 4.
- Gupta A, Gupte N, Sastry J, Bharucha KE, Bhosale R, Kulkarni P, Tripathy S, Nayak U, Phadke M, Bollinger RC; BJMC-JHU MIT Study Team. Mother-to-child transmission of HIV among women who chose not to exclusively breastfeed their infants in Pune, India. Indian J Med Res. 2007 Aug;126(2):131-4.
- Gupta A, Gupte N, Bhosale R, Kakrani A, Kulkarni V, Nayak U, Thakar M, Sastry J, Bollinger RC; Byramji Jeejeebhoy Medical College-Johns Hopkins University Study Group. Low sensitivity of total lymphocyte count as a surrogate marker to identify antepartum and postpartum Indian women who require antiretroviral therapy. J Acquir Immune Defic Syndr. 2007 Nov 1;46(3):338-42. doi: 10.1097/QAI.0b013e318157684b.
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- Ram M, Gupte N, Nayak U, Kinikar AA, Khandave M, Shankar AV, Sastry J, Bollinger RC, Gupta A; SWEN India and BJMC-JHU Clinical Trials Study Team. Growth patterns among HIV-exposed infants receiving nevirapine prophylaxis in Pune, India. BMC Infect Dis. 2012 Oct 31;12:282. doi: 10.1186/1471-2334-12-282.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2002年8月1日
一次修了 (実際)
2007年4月1日
研究の完了 (実際)
2007年9月1日
試験登録日
最初に提出
2003年5月23日
QC基準を満たした最初の提出物
2003年5月27日
最初の投稿 (見積もり)
2003年5月28日
学習記録の更新
投稿された最後の更新 (見積もり)
2008年7月31日
QC基準を満たした最後の更新が送信されました
2008年7月30日
最終確認日
2007年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 5R01AI045462-04 (米国 NIH グラント/契約)
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