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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074399
• Other study ID #: 5R01AI038576-05
• Secondary ID: NIGAT Project
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2003
• Last updated: August 6, 2009
• Start date: February 2001
• Est. completion date: April 2007

Study information

• Verified date: August 2009
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 775
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine
Tablet taken orally daily. Dosage depends on age and body surface area
• Nevirapine placebo
Placebo tablet taken orally daily

Locations

Country	Name	City	State
Ethiopia	Tikur Anbessa Hospital	Addis Ababa

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant HIV infection status		At Months 6 and 12	No
Secondary	Infant mortality rate		Throughout study	Yes
Secondary	Infant morbidity rate		Throughout study	Yes

External Links

•   Click here for more information on nevirapine