drugset / Trial / NCT00386230
Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
Phase 3
Completed
1554 enrolled
Research Institute for Development
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabHarvard School of Public Health (HSPH) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child transmission of HIV: and to assess and compare the safety and tolerance of the long and shortened ZDV regimens.
Timeline
- Start
- 1997-06
- Primary completion
- —
- Completion
- 2000-08
Outcome
Missed primary endpoint
paper At the first interim analysis, the rates of HIV transmission were 4.1 percent for the long-long regimen and 10.5 percent for the short-short regimen (P=0.004). PMID 11018164 ↗
paper The short-short zidovudine regimen is inferior to the long-long regimen and leads to a higher rate of perinatal HIV transmission. PMID 11018164 ↗
Publications
- Results Lallemant M, Jourdain G, Le Coeur S, Kim S, Koetsawang S, Comeau AM, Phoolcharoen W, Essex M, McIntosh K, Vithayasai V. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators. N Engl J Med. 2000 Oct 5;343(14):982-91. doi: 10.1056/NEJM200010053431401.
- Sripan P, Le Coeur S, Amzal B, Ingsrisawang L, Traisathit P, Ngo-Giang-Huong N, McIntosh K, Cressey TR, Sangsawang S, Rawangban B, Kanjanavikai P, Treluyer JM, Jourdain G, Lallemant M, Urien S. Modeling of In-Utero and Intra-Partum Transmissions to Evaluate the Efficacy of Interventions for the Prevention of Perinatal HIV. PLoS One. 2015 May 19;10(5):e0126647. doi: 10.1371/journal.pone.0126647. eCollection 2015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zidovudine | Small molecule | 2 mg/kg | Oral |
| Subject | Zidovudine | Small molecule | 300 mg | Oral |