Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219

M. Culnane, M. G. Fowler, S. Lee, George McSherry, L. Mofcnson, S. Gortmaker, D. E. Shapiro, K. O'Donneii, B. A. Cunningham, J. M. Oleske

Research output: Contribution to journalArticle

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Abstract

Background/Aim: ZDV is widely used in the US for preventing HIV mother-infant transmission (MIT). Late effects of IU ZDV exposure are unknown. IU ZDV exposed infants were evaluated for adverse effects 2yrs after the conclusion of 076. Methods: 66% of infants randomized to ZDV or PL intrapartum & 6wks post birth (076), were enrolled in ACTG 219, a cohort study providing follow-up for PACTG patients (pts) thru 21yrs. Data assessing growth, cognitive, immune status, & other organ system toxicity are collected every 6mo for HIV+ & HIV- infants <24mo of age & yearly thereafter (except cognitive testing). Baseline echocardiogram & fundoscopic exams were collected at 36mo. Results: Data were available on 230 seroreverters (121 ZDV exposed). Pts median age 3.4yrs (range 2.4-4.9). Mat & infant characteristics are similar to the original 076 pts No unexpected opthamology diagnosis (dx), cardiac dx, neoplasms or other organ system dx were reported. CD4 & CD8 measurements, growth, & cognitive data (see below) reveal no difference for ZDV vs. PL infants. Bayley Scores McCarthy Scores months mental motor GCI ZDV PL ZDV PL ZDV PL 18 (15-21) 97.2 93.5 99.0 97.4 NA NA 24 (21-30.5) 94.0 89.8 101.6 101.5 NA NA 36 (28.5-54) NA NA NA NA 87.6 87.6 Conclusion: 076/219 pts evaluation reveal no adverse effects for ZDV IU exposed infants followed as long as 4yrs. While data are reassuring, continued prospective evaluations of perinatally exposed infants (to ZDV & other antiviral or immunotherapy agents) are critical to assess long term safety of successful HIV MIT prevention strategies.

Original languageEnglish (US)
Number of pages1
JournalClinical Infectious Diseases
Volume25
Issue number2
StatePublished - Dec 1 1997

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HIV
Mothers
Heart Neoplasms
Growth
Immunotherapy
Antiviral Agents
Cohort Studies
Parturition
Safety

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Culnane, M. ; Fowler, M. G. ; Lee, S. ; McSherry, George ; Mofcnson, L. ; Gortmaker, S. ; Shapiro, D. E. ; O'Donneii, K. ; Cunningham, B. A. ; Oleske, J. M. / Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219. In: Clinical Infectious Diseases. 1997 ; Vol. 25, No. 2.
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title = "Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219",
abstract = "Background/Aim: ZDV is widely used in the US for preventing HIV mother-infant transmission (MIT). Late effects of IU ZDV exposure are unknown. IU ZDV exposed infants were evaluated for adverse effects 2yrs after the conclusion of 076. Methods: 66{\%} of infants randomized to ZDV or PL intrapartum & 6wks post birth (076), were enrolled in ACTG 219, a cohort study providing follow-up for PACTG patients (pts) thru 21yrs. Data assessing growth, cognitive, immune status, & other organ system toxicity are collected every 6mo for HIV+ & HIV- infants <24mo of age & yearly thereafter (except cognitive testing). Baseline echocardiogram & fundoscopic exams were collected at 36mo. Results: Data were available on 230 seroreverters (121 ZDV exposed). Pts median age 3.4yrs (range 2.4-4.9). Mat & infant characteristics are similar to the original 076 pts No unexpected opthamology diagnosis (dx), cardiac dx, neoplasms or other organ system dx were reported. CD4 & CD8 measurements, growth, & cognitive data (see below) reveal no difference for ZDV vs. PL infants. Bayley Scores McCarthy Scores months mental motor GCI ZDV PL ZDV PL ZDV PL 18 (15-21) 97.2 93.5 99.0 97.4 NA NA 24 (21-30.5) 94.0 89.8 101.6 101.5 NA NA 36 (28.5-54) NA NA NA NA 87.6 87.6 Conclusion: 076/219 pts evaluation reveal no adverse effects for ZDV IU exposed infants followed as long as 4yrs. While data are reassuring, continued prospective evaluations of perinatally exposed infants (to ZDV & other antiviral or immunotherapy agents) are critical to assess long term safety of successful HIV MIT prevention strategies.",
author = "M. Culnane and Fowler, {M. G.} and S. Lee and George McSherry and L. Mofcnson and S. Gortmaker and Shapiro, {D. E.} and K. O'Donneii and Cunningham, {B. A.} and Oleske, {J. M.}",
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Culnane, M, Fowler, MG, Lee, S, McSherry, G, Mofcnson, L, Gortmaker, S, Shapiro, DE, O'Donneii, K, Cunningham, BA & Oleske, JM 1997, 'Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219', Clinical Infectious Diseases, vol. 25, no. 2.

Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219. / Culnane, M.; Fowler, M. G.; Lee, S.; McSherry, George; Mofcnson, L.; Gortmaker, S.; Shapiro, D. E.; O'Donneii, K.; Cunningham, B. A.; Oleske, J. M.

In: Clinical Infectious Diseases, Vol. 25, No. 2, 01.12.1997.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Evaluation for late effects of In Utero (IU) ZDV exposure among uninfected infants bom to HIV+ women enrolled in ACTG 076 & 219

AU - Culnane, M.

AU - Fowler, M. G.

AU - Lee, S.

AU - McSherry, George

AU - Mofcnson, L.

AU - Gortmaker, S.

AU - Shapiro, D. E.

AU - O'Donneii, K.

AU - Cunningham, B. A.

AU - Oleske, J. M.

PY - 1997/12/1

Y1 - 1997/12/1

N2 - Background/Aim: ZDV is widely used in the US for preventing HIV mother-infant transmission (MIT). Late effects of IU ZDV exposure are unknown. IU ZDV exposed infants were evaluated for adverse effects 2yrs after the conclusion of 076. Methods: 66% of infants randomized to ZDV or PL intrapartum & 6wks post birth (076), were enrolled in ACTG 219, a cohort study providing follow-up for PACTG patients (pts) thru 21yrs. Data assessing growth, cognitive, immune status, & other organ system toxicity are collected every 6mo for HIV+ & HIV- infants <24mo of age & yearly thereafter (except cognitive testing). Baseline echocardiogram & fundoscopic exams were collected at 36mo. Results: Data were available on 230 seroreverters (121 ZDV exposed). Pts median age 3.4yrs (range 2.4-4.9). Mat & infant characteristics are similar to the original 076 pts No unexpected opthamology diagnosis (dx), cardiac dx, neoplasms or other organ system dx were reported. CD4 & CD8 measurements, growth, & cognitive data (see below) reveal no difference for ZDV vs. PL infants. Bayley Scores McCarthy Scores months mental motor GCI ZDV PL ZDV PL ZDV PL 18 (15-21) 97.2 93.5 99.0 97.4 NA NA 24 (21-30.5) 94.0 89.8 101.6 101.5 NA NA 36 (28.5-54) NA NA NA NA 87.6 87.6 Conclusion: 076/219 pts evaluation reveal no adverse effects for ZDV IU exposed infants followed as long as 4yrs. While data are reassuring, continued prospective evaluations of perinatally exposed infants (to ZDV & other antiviral or immunotherapy agents) are critical to assess long term safety of successful HIV MIT prevention strategies.

AB - Background/Aim: ZDV is widely used in the US for preventing HIV mother-infant transmission (MIT). Late effects of IU ZDV exposure are unknown. IU ZDV exposed infants were evaluated for adverse effects 2yrs after the conclusion of 076. Methods: 66% of infants randomized to ZDV or PL intrapartum & 6wks post birth (076), were enrolled in ACTG 219, a cohort study providing follow-up for PACTG patients (pts) thru 21yrs. Data assessing growth, cognitive, immune status, & other organ system toxicity are collected every 6mo for HIV+ & HIV- infants <24mo of age & yearly thereafter (except cognitive testing). Baseline echocardiogram & fundoscopic exams were collected at 36mo. Results: Data were available on 230 seroreverters (121 ZDV exposed). Pts median age 3.4yrs (range 2.4-4.9). Mat & infant characteristics are similar to the original 076 pts No unexpected opthamology diagnosis (dx), cardiac dx, neoplasms or other organ system dx were reported. CD4 & CD8 measurements, growth, & cognitive data (see below) reveal no difference for ZDV vs. PL infants. Bayley Scores McCarthy Scores months mental motor GCI ZDV PL ZDV PL ZDV PL 18 (15-21) 97.2 93.5 99.0 97.4 NA NA 24 (21-30.5) 94.0 89.8 101.6 101.5 NA NA 36 (28.5-54) NA NA NA NA 87.6 87.6 Conclusion: 076/219 pts evaluation reveal no adverse effects for ZDV IU exposed infants followed as long as 4yrs. While data are reassuring, continued prospective evaluations of perinatally exposed infants (to ZDV & other antiviral or immunotherapy agents) are critical to assess long term safety of successful HIV MIT prevention strategies.

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M3 - Article

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