drugset / Trial / NCT01618305

Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission

Phase 4 Completed 408 enrolled Westat Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late stages of pregnancy need an effective medication regimen to reduce the risk of transmitting HIV to their children. This study examined the virologic response, safety, and tolerability of two different ARV medication regimens in HIV-infected pregnant women who were between 20 and 36 weeks pregnant when they entered the study.

Timeline

Start: 2013-09-05
Primary completion: 2018-12-11
Completion: 2018-12-11

Outcome

Mixed primary results

paper 144 (94%) women in the raltegravir group and 129 (84%) in the efavirenz group met the primary efficacy outcome PMID 32386720 ↗

registry analysis (superiority test); Arm A (Women) vs Arm B (Women); p = 0.557; Cochran-Mantel-Haenszel NCT01618305 ↗

registry analysis (superiority test); Arm A (Women) vs Arm B (Women); p = 0.909; Cochran-Mantel-Haenszel NCT01618305 ↗

registry analysis (superiority test); Arm A (Infants) vs Arm B (Infants); p = 0.938; Cochran-Mantel-Haenszel NCT01618305 ↗

Publications

Joao EC, Morrison RL, Shapiro DE, Chakhtoura N, Gouvea MIS, de Lourdes B Teixeira M, Fuller TL, Mmbaga BT, Ngocho JS, Njau BN, Violari A, Mathiba R, Essack Z, Pilotto JHS, Moreira LF, Rolon MJ, Cahn P, Prommas S, Cressey TR, Chokephaibulkit K, Werarak P, Laimon L, Hennessy R, Frenkel LM, Anthony P, Best BM, Siberry GK, Mirochnick M. Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial. Lancet HIV. 2020 May;7(5):e322-e331. doi: 10.1016/S2352-3018(20)30038-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavirenz	Other / unclassified	600 mg	—
Subject	Raltegravir	Other / unclassified	400 mg	—
Background	Lamivudine	Other / unclassified	150 mg	—
Background	Zidovudine	Small molecule	300 mg	—