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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074399
First Posted: December 15, 2003
Last Update Posted: August 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074399


Locations
Ethiopia
Tikur Anbessa Hospital
Addis Ababa, Ethiopia
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

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 ( U.S. NIH Grant/Contract )
NIGAT Project
First Submitted: December 11, 2003
First Posted: December 15, 2003
Last Update Posted: August 7, 2009
Last Verified: August 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers