Table 5.

Ongoing and Planned Clinical Trials in Pregnant Women (Current as of October 2015)

Study	Regimen	Status	Study Population	Sponsor
Prevention
IMPAACT P1078 NCT01494038	Evaluating the safety of immediate vs deferred isoniazid preventive therapy among HIV-infected pregnant women	Enrolling (results expected in 2017)	HIV-positive pregnant women without active tuberculosis in settings with a high tuberculosis burden (Haiti, India, sub-Saharan Africa, Thailand)	NIH, IMPAACT
IMPAACT P2001a	PK, tolerability, and safety of once-weekly rifapentine and isoniazid in HIV-infected and HIV-uninfected pregnant and postpartum women with latent tuberculosis infection	In development	Pregnant women (HIV positive and HIV negative) with latent tuberculosis infection or known recent exposure to pulmonary tuberculosis	NIH, IMPAACT
IMPAACT/ACTG PHOENIxa	Evaluating efficacy of delamanid vs isonaizid for HIV-infected and uninfected persons exposed to MDR tuberculosis	In development	Children and adult household contacts of patients with MDR tuberculosis, with possible inclusion of postpartum women	NIH, IMPAACT, ACTG
Treatment
IMPAACT P1026s NCT00042289	PK study of antiretroviral drugs and related drugs during and after pregnancy	Enrolling (results expected 2016); in development	HIV-infected and uninfected pregnant and postpartum women on first-line tuberculosis treatment; HIV-infected and uninfected pregnant and postpartum women receiving treatment for MDR tuberculosis	NIH, IMPAACT

Abbreviations: ACTG, AIDS Clinical Trials Group; HIV, human immunodeficiency virus; IMPAACT, International Maternal Pediatric Adolescent AIDS Clinical Trials Network; MDR, multidrug resistant; NIH, National Institutes of Health; PHOENIx, Protecting Households On Exposure to Newly Diagnosed Index; PK, pharmacokinetic.

^a Data from the IMPAACT Web site [63].