Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099359
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2004-12-10
Brief Title:
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission The one drug standard treatment and two combinations to be studied are 1 zidovudine 2 zidovudinenevirapine and 3 zidovudinelamivudinenelfinavir
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 who are not identified as HIV-1-infected andor are not provided with antiretroviral therapy The optimum treatment strategy for prevention of transmission of HIV-1 to infants born to these women is unknown No trials have evaluated the efficacy of neonatal antiretroviral therapy alone but observational data suggest benefit from zidovudine ZDV therapy given to the infant beginning within 48 hours of birth and continued for six weeks This protocol will compare the safety and efficacy of three antiretroviral regimens administered in the neonatal period Arm A- ZDV Arm B- ZDV plus nevirapine NVP and Arm C- ZDV plus nelfinavir NFV and lamivudine 3TC Two regimens were selected based on expected antiretroviral activity pharmacokinetic data and toxicity profiles Standard of care 6 weeks of ZDV alone will be compared to the 6 weeks of ZDV plus either 3 doses of NVP or 2 weeks of 3TC and NFV Arm B ZDV NVP is the regimen expected to provide the best profile when factors of efficacy safety cost acceptability and convenience are considered The comparison of Arms B and C is also of considerable interest since the 2-drug Arm B is easier to implement and less expensive than the triple drug Arm C Although triple drug therapies have been recommended for post-exposure prophylaxis for needle-stick injuries in high-risk circumstances it is unknown whether the triple drug arm will provide better efficacy than the 2-drug arm for post-exposure prophylaxis of the infant
This open-label study is expected to accrue 1731 infants of women identified in labor as being HIV positive or who are HIV positive but have not received antiretroviral medication during the pregnancy If eligible the infant will be randomized at birth to one of three aforementioned treatment arms Medical history social demographic physical exam RNA and T- lymphocyte data are collected on the mother during the delivery visit The infant will have a birth visit and then return for 1-week 2-week 4-week 3-month and a final 6-month visit Infant evaluations will include a medical history and physical exam DNA testing CBC and liver function tests cells for long-term storage and RNACD4CD8 testing if HIV positive The initial study drug doses will be given to the infant while in the hospital Mothers will administer the infants remaining treatment doses at home depending on ability
This open-label study is expected to accrue 1731 infants of women identified in labor as being HIV positive or who are HIV positive but have not received antiretroviral medication during the pregnancy If eligible the infant will be randomized at birth to one of three aforementioned treatment arms Medical history social demographic physical exam RNA and T- lymphocyte data are collected on the mother during the delivery visit The infant will have a birth visit and then return for 1-week 2-week 4-week 3-month and a final 6-month visit Infant evaluations will include a medical history and physical exam DNA testing CBC and liver function tests cells for long-term storage and RNACD4CD8 testing if HIV positive The initial study drug doses will be given to the infant while in the hospital Mothers will administer the infants remaining treatment doses at home depending on ability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None