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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Nevirapine Drug: Nevirapine placebo	Phase III

MedlinePlus related topics:

AIDS Breast Feeding

ChemIDplus related topics:

Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Infant HIV infection status [ Time Frame: At Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Infant mortality rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Infant morbidity rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	775
Study Start Date:	February 2001
Estimated Study Completion Date:	August 2009
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive nevirapine for 6 weeks	Drug: Nevirapine Tablet taken orally daily. Dosage depends on age and body surface area
2: Placebo Comparator Participants will receive nevirapine placebo for 6 weeks	Drug: Nevirapine placebo Placebo tablet taken orally daily

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074399

Locations


Ethiopia
	Tikur Anbessa Hospital
	Addis Ababa, Ethiopia

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Click here for more information on nevirapine This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Responsible Party:	Johns Hopkins University ( Elham Hassen, MD )
Study ID Numbers:	5R01AI038576-05, NIGAT Project
First Received:	December 11, 2003
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00074399
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Maternal/Infant Transmisson

Vertical Transmission

Pregnancy

HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases

Nevirapine

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Anti-HIV Agents

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00074399