Status:
COMPLETED
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Disease Transmission, Vertical
Vertical Human Immunodeficiency Virus Transmission
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE3
Brief Summary
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different comb...
Detailed Description
Despite the notable reductions in perinatal transmission of HIV-1 with antiretroviral therapy and other interventions, perinatal transmission continues to occur at rates of 20-30% among pregnant women...
Eligibility Criteria
Inclusion
- Infants who meet all of the following criteria are eligible for the study:
- Mother known to be HIV-1-infected prior to labor or identified at the time of labor or \<48 hours postpartum. HIV-1 infection for the purposes of enrollment into this study is defined as: (a) Single positive HIV-1 rapid test in mother or her infant; or (b) Historical documentation of a positive HIV-1 diagnostic test confirmed by repeat diagnostic testing for HIV-1 according to country guidelines in mother (written documentation of test results must be present in the medical record).
- Maternal written informed consent for study participation.
- Mother has not received any antiretroviral therapy during the current pregnancy prior to the onset of labor and delivery; women may have received intravenous or oral ZDV during labor. Women may have received any antiretroviral therapy in previous pregnancies for prevention of vertical HIV-1 transmission.
- Infant is \<48 hours old. Infant may have received up to 48 hours of ZDV as standard care before study enrollment.
Exclusion
- Infants who meet any of the following criteria will be excluded from the study:
- Extreme prematurity (\< 32 weeks of gestation).
- Birth weight \<1500 grams.
- Presence of life-threatening conditions.
- Inability to take oral medication throughout the first 48 hours of life (must be able to receive oral medication by age 48 hours).
- Maternal inability to provide informed consent because of a lack of a conscious state, psychiatric conditions, or language barriers.
- Mother received any antiretroviral therapy during labor and delivery other than intravenous or oral ZDV.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
1735 Patients enrolled
Trial Details
Trial ID
NCT00099359
Start Date
February 1 2004
End Date
February 1 2011
Last Update
December 4 2012
Active Locations (17)
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1
Miller Children's Hospital
Long Beach, California, United States, 90806
2
University of FL
Gainesville, Florida, United States, 32610-0296
3
University of FL-HSC
Jacksonville, Florida, United States, 32209
4
University Medical and Dental School of NJ-Newark Campus
Newark, New Jersey, United States, 07103