Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
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
History of Changes
Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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 ]
Secondary Outcome Measures:
  • Infant mortality rate [ Time Frame: Throughout study ]
  • Infant morbidity rate [ Time Frame: Throughout study ]

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
Experimental: 1
Participants will receive nevirapine for 6 weeks
Drug: Nevirapine

Tablet taken orally daily. Dosage depends on age and body surface area

Placebo Comparator: 2
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

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes 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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Elham Hassen, MD, Johns Hopkins University  
ClinicalTrials.gov Identifier: NCT00074399   History of Changes  
Other Study ID Numbers: 5R01AI038576-05  
  NIGAT Project  
Study First Received: December 11, 2003  
Last Updated: August 6, 2009  

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

Maternal/Infant Transmisson
Vertical Transmission
Pregnancy
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Nevirapine

ClinicalTrials.gov processed this data on October 18, 2019
This information is provided by ClinicalTrials.gov.