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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Breast Feeding

Drug Information available for: Nevirapine

U.S. FDA Resources

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
Study Completion Date:	April 2007
Primary Completion Date:	April 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

Additional Information:

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

No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	December 11, 2003
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00074399 History of Changes
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

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Nevirapine
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 05, 2009