Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000590
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
1999-10-27
Brief Title:
Anti-HIV Immunoglobulin HIVIG in Prevention of Maternal-Fetal HIV Transmission Pediatric ACTG Protocol 185
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
To determine if HIV hyperimmune globulin HIVIG given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases The trial was Pediatric ACTG Protocol 185
Detailed Description:
BACKGROUND
The HIV epidemic in the United States has changed its course in the past few years The main risk group of the past homosexual males has reduced numbers of new infections because of education and prevention Other groups including intravenous drug abusers disadvantaged urban socioeconomic classes and adolescents continue to be infected and to transmit HIV by needle sharing andor unprotected heterosexual activity Many of these newly infected individuals are women of child-bearing age These women in turn infect their children The Centers for Disease Control estimates that there will be 2000 infected infants born to 6000 HIV-positive mothers annually in the United States
Over the past few years several studies have identified the risk of maternal-fetal transmission of HIV by seropositive mothers The risk is close to 30 percent However for reasons not yet understood the risk appears to be higher in Africa approaching 40 percent and lower in Europe approaching 16 percent Factors influencing maternal-fetal transmission of HIV are not well defined but may include the clinical state of the mother plasma p24 antigen positivity of the mother viral load prior pregnancy associated with maternal-fetal HIV transmission absence of maternal epitope specific andor high affinity gp120 antibodies or prematurity
The results of a Phase III multicenter double-blind randomized placebo-controlled clinical trial to evaluate the efficacy safety and tolerance of zidovudine for the prevention of HIV transmission from infected pregnant women to their infants ACTG protocol 076 provided for the first time proof of the concept that a preventive intervention can reduce vertical HIV transmission 47 Based on analysis of data for 364 evaluable births zidovudine ZDV or AZT treatment according to the regimen employed in ACTG 076 appeared to reduce the risk of HIV transmission by two thirds from 255 percent to 83 percent Eligible subjects were HIV-infected pregnant women who had received no antiretroviral therapy during their current pregnancy who had no maternal clinical indications for antiretroviral therapy and who had CD4 T-lymphocyte counts above 200 per microliter at study entry
Efficacy of ZDV for reduction of vertical HIV transmission in women with advanced HIV disease who are already receiving antiretroviral treatment according to current clinical indications for their own health or with CD4 T-lymphocyte counts of 200 per microliter or below or both was not evaluated in ACTG 076
Administration of an antiretroviral agent to a pregnant woman in theory could reduce the risk of neonatal infection by reducing the exposure of the fetus to maternal virus or by prophylaxis of the fetus prior to exposure Because it is postulated that intense exposure of a potentially uninfected fetus to HIV present in maternal blood and genital tract secretions occurs during parturition the design of this study includes intrapartum administration of ZDV followed by six weeks of oral ZDV to the infant
An identical regimen for ZDV administration was employed in ACTG Protocol 076
Pediatric ACTG Protocol 185 evaluated the hypothesis that in HIV-infected pregnant women receiving oral ZDV for medical indications HIVIG administered monthly beginning at 20-30 weeks gestation in combination with intravenous ZDV intrapartum together with a single newborn dose of HIVIG within 12 hours after birth in combination with six weeks of newborn oral ZDV would reduce vertical HIV transmission compared with IVIG administered identically as a control agent
DESIGN NARRATIVE
Randomized double-blind controlled Approximately half of the women were given intravenous HIVIG every four weeks until delivery The other half received standard intravenous immunoglobulin IVIG without anti-HIV antibody Both groups received AZT A similar dose of HIVIG or IVIG was given to the newborn infant within 12 hours of birth Each infant of a multiple birth received the mothers randomized study drug Infant blood samples were taken at birth and at several intervals during the first 24 months of life to determine the infants HIV status by p24 antigen assays plasma viremia or HIV co-culture assays An existing NICHD contract with Westat Inc was used to conduct the trial Westat the study coordinating center subcontracted to 25 NICHD clinical trial units An approximately similar number of NIAID clinical trial units also participated in the trial As of February 1 1996 there were 51 clinical trial units participating Data analysis was performed by Westat In 1993 NHLBI contracted with North American Biologics to supply HIVIG The trial ended in December 1996
The HIV epidemic in the United States has changed its course in the past few years The main risk group of the past homosexual males has reduced numbers of new infections because of education and prevention Other groups including intravenous drug abusers disadvantaged urban socioeconomic classes and adolescents continue to be infected and to transmit HIV by needle sharing andor unprotected heterosexual activity Many of these newly infected individuals are women of child-bearing age These women in turn infect their children The Centers for Disease Control estimates that there will be 2000 infected infants born to 6000 HIV-positive mothers annually in the United States
Over the past few years several studies have identified the risk of maternal-fetal transmission of HIV by seropositive mothers The risk is close to 30 percent However for reasons not yet understood the risk appears to be higher in Africa approaching 40 percent and lower in Europe approaching 16 percent Factors influencing maternal-fetal transmission of HIV are not well defined but may include the clinical state of the mother plasma p24 antigen positivity of the mother viral load prior pregnancy associated with maternal-fetal HIV transmission absence of maternal epitope specific andor high affinity gp120 antibodies or prematurity
The results of a Phase III multicenter double-blind randomized placebo-controlled clinical trial to evaluate the efficacy safety and tolerance of zidovudine for the prevention of HIV transmission from infected pregnant women to their infants ACTG protocol 076 provided for the first time proof of the concept that a preventive intervention can reduce vertical HIV transmission 47 Based on analysis of data for 364 evaluable births zidovudine ZDV or AZT treatment according to the regimen employed in ACTG 076 appeared to reduce the risk of HIV transmission by two thirds from 255 percent to 83 percent Eligible subjects were HIV-infected pregnant women who had received no antiretroviral therapy during their current pregnancy who had no maternal clinical indications for antiretroviral therapy and who had CD4 T-lymphocyte counts above 200 per microliter at study entry
Efficacy of ZDV for reduction of vertical HIV transmission in women with advanced HIV disease who are already receiving antiretroviral treatment according to current clinical indications for their own health or with CD4 T-lymphocyte counts of 200 per microliter or below or both was not evaluated in ACTG 076
Administration of an antiretroviral agent to a pregnant woman in theory could reduce the risk of neonatal infection by reducing the exposure of the fetus to maternal virus or by prophylaxis of the fetus prior to exposure Because it is postulated that intense exposure of a potentially uninfected fetus to HIV present in maternal blood and genital tract secretions occurs during parturition the design of this study includes intrapartum administration of ZDV followed by six weeks of oral ZDV to the infant
An identical regimen for ZDV administration was employed in ACTG Protocol 076
Pediatric ACTG Protocol 185 evaluated the hypothesis that in HIV-infected pregnant women receiving oral ZDV for medical indications HIVIG administered monthly beginning at 20-30 weeks gestation in combination with intravenous ZDV intrapartum together with a single newborn dose of HIVIG within 12 hours after birth in combination with six weeks of newborn oral ZDV would reduce vertical HIV transmission compared with IVIG administered identically as a control agent
DESIGN NARRATIVE
Randomized double-blind controlled Approximately half of the women were given intravenous HIVIG every four weeks until delivery The other half received standard intravenous immunoglobulin IVIG without anti-HIV antibody Both groups received AZT A similar dose of HIVIG or IVIG was given to the newborn infant within 12 hours of birth Each infant of a multiple birth received the mothers randomized study drug Infant blood samples were taken at birth and at several intervals during the first 24 months of life to determine the infants HIV status by p24 antigen assays plasma viremia or HIV co-culture assays An existing NICHD contract with Westat Inc was used to conduct the trial Westat the study coordinating center subcontracted to 25 NICHD clinical trial units An approximately similar number of NIAID clinical trial units also participated in the trial As of February 1 1996 there were 51 clinical trial units participating Data analysis was performed by Westat In 1993 NHLBI contracted with North American Biologics to supply HIVIG The trial ended in December 1996
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: