# Comprehensive HIV+/- Analysis of iNflammation in transGender women on Estrogen Supplementation: The CHANGES Study

> **NIH NIH R21** · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · 2020 · $178,526

## Abstract

PROJECT SUMMARY
The physiologic intersections of HIV, antiretroviral therapy (ART) and feminizing hormonal therapy (FHT) are
critical but incompletely understood elements of optimizing care for transgender women (TW). Worldwide, HIV
prevalence rates among TW have reached epidemic levels. HIV infection is characterized by persistent
inflammation and immune activation that contributes to multiple metabolic disturbances. ART also contributes
to these disturbances, and FHT modulates inflammatory, metabolic, and coagulation pathways and causes
gain of fat and loss of lean mass. However, the degree to which these perturbations translate into altered
cardiometabolic disease risk is not well understood, particularly in the setting of concomitant HIV infection.
The Féminas study enrolled 220 adult TW in Lima, Peru for extensive sociodemographic and biologic
characterization and access to standardized FHT and ART for HIV treatment or HIV pre-exposure prophylaxis
(PrEP), depending upon HIV serostatus. Serum and plasma samples were collected pre- and post-FHT and
PrEP or ART (hereafter referred to jointly as ART). Using data and stored samples from Féminas participants
and complementary in vitro experiments, we aim to determine how the intersections of HIV infection, ART and
FHT affect inflammatory pathways and cardiometabolic risk in TW. Specifically, we aim: 1) To determine the
individual and combined in vivo effects of HIV, ART and FHT on circulating metabolic, inflammatory and
coagulation biomarkers in Féminas participants; and 2) To determine the individual and combined in vitro
effects of HIV, ART and FHT on immune and cellular function. We hypothesize that HIV+ TW will have greater
perturbations in biomarker profiles than HIV- TW pre-FHT and/or pre-ART, that FHT and ART will induce
overlapping but unique changes in inflammatory and metabolic profiles that are greater than the changes seen
in HIV- TW initiating FHT alone, and that changes in biomarker profiles will be associated with available
estimates of clinical disease. We also hypothesize that the concentrations of estrogen provided as FHT in
Féminas (approximately 120 pg/mL estradiol and 600 pg/mL estrone) will lead to significant changes in cellular
activation, immuno-metabolic cytokine profiles, and estrogen and androgen receptor expression that differ by
HIV and ART status. This pilot project will elucidate mechanisms of cardiometabolic disease risk and immuno-
metabolic perturbations in TW on FHT, including whether inflammatory and metabolic changes induced by
FHT  ART are antagonistic, additive or synergistic. These data are extremely novel, have not previously been
documented in the setting of HIV and modern FHT, and aim to inform care and improve quality of life for TW.

## Key facts

- **NIH application ID:** 9832665
- **Project number:** 5R21AI143452-02
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
- **Principal Investigator:** Nicholas T. Funderburg
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $178,526
- **Award type:** 5
- **Project period:** 2018-12-06 → 2020-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9832665

## Citation

> US National Institutes of Health, RePORTER application 9832665, Comprehensive HIV+/- Analysis of iNflammation in transGender women on Estrogen Supplementation: The CHANGES Study (5R21AI143452-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9832665. Licensed CC0.

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