IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
Summary
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.
Timeline
- Start
- 2010-01-01
- Primary completion
- 2016-08-31
- Completion
- 2016-08-31
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); Continue HAART vs Stop HAART; p = 0.54; Hazard Ratio (HR) 0.68 (95% CI 0.19 to 2.40) NCT00955968 ↗
paper the primary composite endpoint rate was significantly lower than expected, and not significantly different between arms PMID 28489856 ↗
Publications
- Background U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com
- Background Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010.
- Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, Santos B, Aurpibul L, Losso M, Pierre MF, Weinberg A, Gnanashanmugam D, Chakhtoura N, Klingman K, Browning R, Coletti A, Mofenson L, Shapiro D, Pilotto J; 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 >/= 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | — | — |
| Subject | Didanosine | Small molecule | — | — |
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Lopinavir | Other / unclassified | — | — |
| Subject | Raltegravir | Other / unclassified | — | — |
| Subject | Rilpivirine | Small molecule | — | — |
| Subject | Ritonavir | Other / unclassified | — | — |
| Subject | Tenofovir | Small molecule | — | — |
| Subject | Zidovudine | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |