Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00074399
First received: December 11, 2003
Last updated: August 6, 2009
Last verified: August 2009

December 11, 2003
August 6, 2009
February 2001
April 2007   (final data collection date for primary outcome measure)
Infant HIV infection status [ Time Frame: At Months 6 and 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00074399 on ClinicalTrials.gov Archive Site
  • Infant mortality rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Infant morbidity rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well. This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed.

A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission. NVP's long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
HIV Infections
  • Drug: Nevirapine
    Tablet taken orally daily. Dosage depends on age and body surface area
  • Drug: Nevirapine placebo
    Placebo tablet taken orally daily
  • Experimental: 1
    Participants will receive nevirapine for 6 weeks
    Intervention: Drug: Nevirapine
  • Placebo Comparator: 2
    Participants will receive nevirapine placebo for 6 weeks
    Intervention: Drug: Nevirapine placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
775
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection, documented on two separate specimens
  • Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height
  • Permanent residency in Addis Ababa
  • Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)
  • Hemoglobin >= 7.5 gm/dl within 4 weeks prior to study entry
  • Serum glutamic pyruvic transaminase (SGPT) < 5 times upper limit of normal within 4 weeks prior to study entry
  • Serum creatinine < 1.5 mg/dl within 4 weeks prior to study entry
  • Consent form signed by the mother and, when possible, by the father, prior to the onset of labor
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00074399
5R01AI038576-05, NIGAT Project
Not Provided
Elham Hassen, MD, Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP