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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

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
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

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 ClinicalTrials.gov Identifier (NCT Number):

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
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Nevirapine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013