HIV Infections Clinical Trial
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.
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 and/or 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 2,000 infected infants born to
6,000 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 and/or 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 25.5 percent to 8.3 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 mother's 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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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