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Evevident
Original paper
1994NEJMInfectious Disease

ACTG 076

Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment

RCTPerinatal HIV prevention

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Overview

Zidovudine dramatically reduced mother-to-infant HIV transmission.

Clinical takeaway

ACTG 076 proved that antiretroviral prophylaxis can prevent vertical HIV transmission, laying the foundation for modern ART-in-pregnancy protocols.

Key result

HIV transmission was reduced from 25.5% with placebo to 8.3% with zidovudine.

Practice impact

Perinatal ART transformed HIV in pregnancy from high transmission risk to largely preventable infection.

Evidence

Study design

Randomized, double-blind, placebo-controlled trial.

Enrollment

477

Follow-up

Infants followed for HIV infection status through early life.

Geography

United States, France

Clinical question

Does zidovudine given during pregnancy, labor, and to the newborn reduce maternal-infant HIV transmission?

Population

  • Pregnant women with HIV-1 infection and CD4 counts above 200 cells/mm3 who had not received antiretroviral therapy during the current pregnancy.

Intervention

Zidovudine during pregnancy and labor plus neonatal zidovudine.

Comparator

Placebo.

Primary outcome

Infant HIV infection.

Zidovudine markedly reduced maternal-infant HIV transmission.

Relative reduction / 67.5 / CI 95% CI 40.7-82.1% / p=0.00006

Key results

  • Maternal-infant HIV transmission: 8.3% with zidovudine vs 25.5% with placebo.
  • Relative reduction in transmission was about two thirds.
  • Short-term maternal and infant safety was acceptable in the trial.

Harms

  • Mild maternal anemia and infant anemia were monitoring concerns.
  • Modern multidrug ART has replaced zidovudine monotherapy for most pregnant patients.

Clinical Use

When to cite

  • When explaining why HIV testing and ART during pregnancy prevent vertical transmission.

Practice impact

  • Established antiretroviral prophylaxis as a central strategy for preventing perinatal HIV transmission.

Applicability

  • Historical foundation for treating HIV during pregnancy and providing neonatal prophylaxis.

Limitations

  • Pre-combination ART era; contemporary management uses suppressive ART regimens, viral load monitoring, and delivery planning.

Common misinterpretations

  • Do not use ACTG 076 to justify zidovudine monotherapy today when full ART is indicated and available.

Related evidence

START - ContextHPTN 052 - Context

Citation

Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331(18):1173-1180. doi:10.1056/NEJM199411033311801

The zidovudine regimen reduced the risk of maternal-infant HIV-1 transmission by approximately two thirds.