Safety of the maternal–infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study

Sperling, Rhoda; Shapiro, David E.; McSherry, George; Britto, Paula; Cunningham, Bethann E.; Culnane, Mary; Coombs, Robert W.; Scott, Gwendolyn B.; Dyke, Russell B. Van; Shearer, William T.; Jiménez, Eleanor; Díaz, Clemente; Harrison, Duane D.; Delfraissy, Jean François

doi:10.1097/00002030-199814000-00012

Cited by 153 publications

(82 citation statements)

References 13 publications

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“…It consisted of an antenatal treatment starting at 14 or 28 weeks gestation, continuing with intravenous intrapartum and then treatment of the neonate for six weeks. The results are similar to those initially reported in 1994; the estimated HIV transmission rate for infants who received the placebo was 22.6%, compared with 7.6% for those who received ZDV, giving a 66% reduction in risk of transmission [8].…”

Section: Mother-to-child Transmissionsupporting

confidence: 87%

“…In PACTG 076 exposed infants, observed mortality at 18 months was 1.4% in ZDV-exposed, compared to 3.5% in placebo infants [8]. In contrast, another clinical study made with 291 infants, 139 of which used ZDV, the rapid disease progression rate was 29.4% in the no ZDV group compared with 70.6% in the ZDV group (p=0.012).…”

Section: Rapid Disease Progression (Rdp)mentioning

confidence: 89%

“…No increased risk was found for newborn structural abnormalities among infants born to women who receive ZDV antenatally, when compared with the general population [8,24].…”

Section: Congenital Abnormalitiesmentioning

confidence: 99%

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Antiretroviral therapy during pregnancy and early neonatal life: consequences for HIV-exposed, uninfected children

Beitune¹,

Duarte²,

Quintana³

et al. 2004

Braz J Infect Dis

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Women have emerged as the fastest growing human immunodeficiency virus (HIV) infected population worldwide, mainly because of the increasing occurrence of heterosexual transmission. Most infected women are of reproductive age and one of the greatest concerns for both women and their physicians is that more than 1,600 infants become infected with HIV each day. Almost all infections are a result of mother-to-child transmission of HIV. With the advent of combination antiretroviral therapies, transmission rates lower than 2% have been achieved in clinical studies. Antiretroviral compounds differ from most other new pharmaceutical agents in that they have become widely prescribed in pregnancy in the absence of proof of safety. We reviewed antiretroviral agents used in pregnant women infected with human immunodeficiency virus, mother-to-child transmission, and their consequences for infants.

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Section: Mother-to-child Transmissionsupporting

confidence: 87%

Section: Rapid Disease Progression (Rdp)mentioning

confidence: 89%

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Antiretroviral therapy during pregnancy and early neonatal life: consequences for HIV-exposed, uninfected children

Beitune¹,

Duarte²,

Quintana³

et al. 2004

Braz J Infect Dis

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“…Several concerns have been raised about the safety of ZDV treatment during pregnancy. First, as with all drugs taken during pregnancy, the potential for teratogenesis must be considered; however, the incidence of birth defects in ZDV-exposed children does not seem to be increased, 5,16 and the ZDV regimen in our trial began after completion of organogenesis. Second, ZDV can be integrated into infant DNA, and animal data suggest the possibility that in utero ZDV exposure can cause tumors.…”

Section: Discussionmentioning

confidence: 96%

“…The only short-term adverse event in children attributed to ZDV in this study was mild anemia that resolved rapidly without intervention. 4,5 Moreover, after an additional 4 years of follow-up of 122 ZDV-exposed children in this trial, no additional adverse events clearly associated with ZDV treatment were identified. 6 Nonetheless, concerns have been raised that prenatal ZDV exposure may cause cancer, mitochondrial toxicity, or other problems.…”

mentioning

confidence: 76%

Safety of Late In Utero Exposure to Zidovudine in Infants Born to Human Immunodeficiency Virus-Infected Mothers: Bangkok

Chotpitayasunondh

Vanprapar²,

Simonds³

et al. 2001

Pediatrics

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ABSTRACT. Background. Short-course zidovudine (ZDV) given in the late antenatal period can reduce mother-infant human immunodeficiency virus (HIV) transmission by one half. Because this intervention is being implemented in developing countries, evidence of its safety is needed.Methods. In a randomized, double-blinded, placebocontrolled trial in Bangkok, HIV-infected pregnant women received either ZDV (300 mg twice daily from 36 weeks' gestation until labor, then every 3 hours until delivery) or an identical placebo regimen. Infants were evaluated at birth and at 1, 2, 4, 6, 9, 12, 15, and 18 months of age. Growth, clinical events, and hematologic and immunologic measurements were compared between treatment groups.Results. Of the 395 children born (196 in ZDV group and 199 in placebo group), 330 were uninfected, 55 were infected, and 10 had indeterminate infection status. Overall, 319 children (81%) completed 18 months of follow-up, and 14 (4%) died before 18 months of age. Among uninfected children, the mean hematocrit was lower in the ZDV group at birth (49.1% vs 51.5%) but not at later ages; mean weight, height, head circumference, and CD4 ؉ and CD8 ؉ T lymphocyte counts were similar in both groups at all ages. Five uninfected children in the ZDV group but only one in the placebo group had a febrile convulsion. No other signs suggestive of mitochondrial dysfunction and no tumors were observed. Among infected children, an estimated 62% in the ZDV group and 77% in the placebo group survived free of Centers for Disease Control and Prevention class C disease during the 18-month follow-up.Conclusions. No significant adverse events were associated with short-course ZDV during 18 months of follow-up in this population. Pediatrics 2001;107(1). URL: http://www.pediatrics.org/cgi/content/full/107/1/e5; zidovudine, vertical HIV transmission, children, disease progression, Thailand.

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Lack of Long-term Effects of In Utero Exposure to Zidovudine Among Uninfected Children Born to HIV-Infected Women

Culnane

Fowler²,

Lee³

et al. 1999

JAMA

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Safety of the maternal–infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study

Abstract: There were no identified problems that would alter current recommendations for the routine use of ZDV for the prevention of mother-child HIV-1 transmission.

Cited by 153 publications

References 13 publications

Antiretroviral therapy during pregnancy and early neonatal life: consequences for HIV-exposed, uninfected children

Antiretroviral therapy during pregnancy and early neonatal life: consequences for HIV-exposed, uninfected children

Safety of Late In Utero Exposure to Zidovudine in Infants Born to Human Immunodeficiency Virus-Infected Mothers: Bangkok

Lack of Long-term Effects of In Utero Exposure to Zidovudine Among Uninfected Children Born to HIV-Infected Women

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