Daily Nevirapine to Prevent Mother to Infant Transmission of HIV - Article
Clinical Trial: Daily Nevirapine to Prevent Mother to Infant Transmission of HIV
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Nevirapine ||Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Prevention of Maternal to Infant HIV Transmission in India
Expected Total Enrollment: 730
Study start: August 2002; Expected completion: May 2007
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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
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
- 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)
Location and Contact Information
BJ Medical College, Pune, India; Recruiting
Robert C. Bollinger, MD, MPH 001-410-614-0936 firstname.lastname@example.org
Robert C. Bollinger, MD, MPH, Principal Investigator, Johns Hopkins University
Publications that report results of this study
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.
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.
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.
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.
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.
Sastry J, Pisal H, Sutar S, Kapadia-Kundu N, Joshi A, Suryavanshi N, Bharucha K, Shrotri A, Phadke M, Bollinger R, Shankar A. Optimizing the HIV/AIDS informed consent process in India. BMC Med. 2004 Aug 2;2(1):28.
Record last reviewed: November 2004
Last Updated: November 29, 2004
Record first received: May 23, 2003
ClinicalTrials.gov Identifier: NCT00061321
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Birds, Infections from (Centers for Disease Control and Prevention)