# SDMC: HPTN 084 Pregnancy Supplement

> **NIH NIH UM1** · FRED HUTCHINSON CANCER CENTER · 2024 · $1,195,111

## Abstract

Abstract (30 lines)
The HPTN 084 OLE allows for participants to discontinue contraception and if becoming pregnant to
continue active dosing with CAB LA throughout pregnancy and breastfeeding. The HPTN 084
pregnancy substudy will provide important information for prevention of HIV in people of reproductive
potential, when they are often most vulnerable to HIV. In addition, the pregnancy substudy will
provide valuable information about the safety and pharmacokinetics of CAB LA for pregnant and
lactating people and their infants.
Specifically, this substudy will contribute information about the incidence of pregnancy in a cohort of
women on oral and long-acting PrEP, assess maternal safety outcomes (Serious adverse events,
AEs, and weight gains), pregnancy outcomes (such as the rates of spontaneous abortion, ectopic
pregnancy, low birthweight, and early or full-term births), and infant safety outcomes (SAEs, AEs, and
growth). In addition, the substudy will assess pharmacokinetic parameters during the pre-pregnant,
pregnant, and post-partum periods, including concentration time profiles and trough CAB
concentrations. Utero/peripartum exposure will also be assessed by examining CAB concentrations
in cord blood and corresponding maternal plasma. Infant exposure through breastmilk will be
examining by analyzing CAB concentrations in maternal plasma, breastmilk, and infant plasma.
The HPTN SDMC, housed at the Fred Hutchinson Cancer Research Center in Seattle, takes
advantage of the strengths of the institution, which also includes the HVTN SDMC. The HPTN SDMC
has faculty biostatisticians experienced in the design, conduct and analysis of global clinical trials and
surveillance studies, who support research through leadership in statistical design, trial conduct and
analysis, and development and implementation of innovative statistical methods as needed and
motivated by the scientific goals. The SDMC provides regulatory compliant data management
functions for all trials it implements, including electronic data capture directly from research sites or
the field, integration of laboratory specimens and assay results, and electronic participant reported
outcomes.

## Key facts

- **NIH application ID:** 11017543
- **Project number:** 3UM1AI068617-19S1
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** Elizabeth Renata Brown
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,195,111
- **Award type:** 3
- **Project period:** 2024-02-01 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11017543

## Citation

> US National Institutes of Health, RePORTER application 11017543, SDMC: HPTN 084 Pregnancy Supplement (3UM1AI068617-19S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11017543. Licensed CC0.

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