Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

NCT00061321 | Completed Phase 3 DMC

• 1 other identifier: 5R01AI045462-04
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Nevirapine; Pregnancy; Maternal to Infant transmission; Infant; Breastfeeding; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• HIV infection rate of infants

  6 months of age

• Safety of the regimens for HIV-infected mothers and their breast-fed infants

  Through 12 months post-partum

Secondary Outcomes (8)

• Acceptability and compliance of intervention regimens

  Until 6 weeks of age

• Time to HIV infection by treatment regimen

  over 12 months of age

• Time to infection by infant feeding practice and time to weaning

  Until 12 months post-partum

• Maternal ZDV and NVP resistance

  Baseline and post-partum

• Infant morbidity and mortality by treatment arm

  Until 12 months post partum

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Nevirapine and mulitvitamins

2

EXPERIMENTAL

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

Drug: Nevirapine and mulitvitamins

Interventions

Nevirapine and mulitvitamins DRUG

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

Also known as: Viramune® (Boehringer Ingelheim)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Planning to breastfeed
• Able to tolerate oral drugs and available for 12 months of postpartum follow-up

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

BJ Medical College

Pune, India

Location

Related Publications (18)

• 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.

  PMID: 15795470 BACKGROUND

• 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.

  PMID: 17991597 BACKGROUND

• 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.

  PMID: 12590791 RESULT

• 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.

  PMID: 12730418 RESULT

• 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.

  PMID: 14519801 RESULT

• 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.

  PMID: 14617507 RESULT

• 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.

  PMID: 14678593 RESULT

• 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.

  PMID: 15287983 RESULT

• 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.

  PMID: 16105190 RESULT

• 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.

  PMID: 17578786 RESULT

• 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.

  PMID: 17932438 RESULT

• 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.

  PMID: 17846559 RESULT

• Gupte N, Sastry J, Brookmeyer R, Phadke MA, Bhosale RA, Bollinger RC; BJ Medical College-National AIDS Research Institute-Johns; Hopkins Univeristy Mother-to-Child Study Group. Declining HIV infection rates among recently married primigravid women in Pune, India. J Acquir Immune Defic Syndr. 2007 Aug 15;45(5):570-3. doi: 10.1097/QAI.0b013e3181161c8b.

  PMID: 17577126 RESULT

• Sinha G, Choi TJ, Nayak U, Gupta A, Nair S, Gupte N, Bulakh PM, Sastry J, Deshmukh SD, Khandekar MM, Kulkarni V, Bhosale RA, Bharucha KE, Phadke MA, Kshirsagar AS, Bollinger RC; Maternal Infant Transmission Study in Pune, India. Clinically significant anemia in HIV-infected pregnant women in India is not a major barrier to zidovudine use for prevention of maternal-to-child transmission. J Acquir Immune Defic Syndr. 2007 Jun 1;45(2):210-7. doi: 10.1097/QAI.0b013e3180556000.

  PMID: 17414927 RESULT

• Shivakoti R, Gupte N, Kumar NP, Kulkarni V, Balasubramanian U, Bhosale R, Sambrey P, Kinikar A, Bharadwaj R, Patil S, Inamdar S, Suryavanshi N, Babu S, Bollinger RC, Gupta A. Intestinal Barrier Dysfunction and Microbial Translocation in Human Immunodeficiency Virus-Infected Pregnant Women Are Associated With Preterm Birth. Clin Infect Dis. 2018 Sep 14;67(7):1103-1109. doi: 10.1093/cid/ciy253.

  PMID: 29590318 DERIVED

• 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.

  PMID: 23114104 DERIVED

• Moorthy A, Gupta A, Bhosale R, Tripathy S, Sastry J, Kulkarni S, Thakar M, Bharadwaj R, Kagal A, Bhore AV, Patil S, Kulkarni V, Venkataramani V, Balasubramaniam U, Suryavanshi N, Ziemniak C, Gupte N, Bollinger R, Persaud D. Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants. PLoS One. 2009;4(1):e4096. doi: 10.1371/journal.pone.0004096. Epub 2009 Jan 1.

  PMID: 19119321 DERIVED

• 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.

  PMID: 18657709 DERIVED

MeSH Terms

Conditions

HIV Infections; Breast Feeding

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert C. Bollinger, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 23, 2003
• First Posted: May 28, 2003
• Study Start: August 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 31, 2008

Record last verified: 2007-08

Locations

IN (1)