Table 4.

Summary of parent protocols linked to the MTN 016 pregnancy registry.

Study name and reference	Type	Sample size of parent study	Dates	Summary	Sites	Mother/infant pairs enrolled statistics
Studies with planned exposures
MTN-0027	Phase I	16	Aug 2008 to Dec 2009	Assessed pharmacokinetic parameters and placental transfer among women given Tenofovir 1% vaginal gel at term within two hours prior to an elective cesarian delivery	Pittsburgh, PA, USA	All 16 mothers and infants were enrolled. Infant retention at one year was 88%
MTN-0086	Phase I	99	Apr 2011 to Jul 2013	Assessed the safety and tolerability of Tenofovir 1% gel used daily for 7 days by healthy women aged 18–40 years in third trimester pregnancy and during lactation	Pittsburgh, PA USA.	Eighty-eight of 99 (89%) pregnant women and 85 (97%) infants enrolled. Infant retention at 12 months was 73%
					Birmingham, Alabama, USA
Effectiveness studies
MTN-0032 (VOICE)	Phase IIb	5029	Sep 2009 to Jun 2011	Double-blinded, five arm safety and effectiveness trial assessing Tenofovir (TDF) 300 mg tablets, Emtricitabine (FTC)/TDF 200/300 mg tablet (Truvada), Tenofovir 1% gel vs. oral placebo tablet and HEC placebo gel for HIV prevention	South Africa, Uganda, and Zimbabwe	Enrolled 213 of 260 (82%) eligible pregnant women and 181 (91%) infants. The 12-month infant retention rate was 89%
MTN-0203 (AS-PIRE)	Phase III	2629	Aug 2012 to Jun 2014	Double-blinded trial evaluating the safety and effectiveness of the 25 mg Dapivirine vaginal ring compared to its placebo for HIV prevention. The ring was changed every 28 to 35 days	Malawi, South Africa, Uganda, and Zimbabwe	Enrolled 104 of 110 (95%) of eligible pregnant women and 99 (97%) infants. The 12 month infant retention rate was 93%