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

Tracking Information
First Received Date ^ICMJE	December 11, 2003
Last Updated Date	August 6, 2009
Start Date ^ICMJE	February 2001
Primary Completion Date	April 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 16, 2008)	Infant HIV infection status [ Time Frame: At Months 6 and 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Infant HIV infection status at 6 and 12 months of age
Change History	Complete list of historical versions of study NCT00074399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 16, 2008)	Infant mortality rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ] Infant morbidity rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Infant mortality rate infant morbidity rate

Descriptive Information
Brief Title ^ICMJE	Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Caregiver), Active Control, Factorial Assignment, Safety/Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Nevirapine Drug: Nevirapine placebo
Study Arms / Comparison Groups	Experimental: Participants will receive nevirapine for 6 weeks Placebo Comparator: Participants will receive nevirapine placebo for 6 weeks
Publications *	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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	775
Completion Date	April 2007
Primary Completion Date	April 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Ethiopia

Administrative Information
NCT ID ^ICMJE	NCT00074399
Responsible Party	Elham Hassen, MD, Johns Hopkins University
Study ID Numbers ^ICMJE	5R01AI038576-05, NIGAT Project
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP