TerminatedPhase 2

Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

Stopped: Trial terminated by Sponsor.

United States93 participantsStarted 2024-01-04

Plain-language summary

Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and increased viral loads. Prior data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. The Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy (GET IT RiGHT) trial aimed to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. This was an open-label, non-randomized, 3-group trial of adult TW and other individuals identifying as female or transfeminine but with male sex assigned at birth living with HIV. Participants were on ART at entry and received study-supplied 17-β estradiol for FHT for up to 48 weeks. The primary objectives of the study were to 1) assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and un-boosted ART regimens.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documentation of HIV-1 status.
✓. On ART for at least 24 weeks prior to study entry. Regimen changes within the 24 weeks prior to study entry are acceptable, but candidates must have been on a stable regimen for at least 28 days prior to study entry.
✓. On BIC/FTC/TAF, DTG/TDF/FTC or 3TC, or DRV/c-containing ART for at least 28 days prior to study entry (single tablet regimen not required), and with no plans to change ART regimen over the study duration of 48 weeks.
✓. Desire to initiate or restart FHT, regardless of orchiectomy status.
✓. HIV-1 RNA \<200 copies/mL at screening.
✓. HIV-1 RNA \<400 copies/mL available through routine clinical care between 24 and 96 weeks prior to study entry and while on ART. The HIV-1 RNA must be the most recent value obtained between 24 and 96 weeks prior to study entry.
✓. The following laboratory values obtained within 60 days prior to study entry
✓. Serum estradiol level \<75 pg/mL within 60 days prior to study entry.

Exclusion criteria

What they're measuring

Geometric Ratio of Antiretroviral Treatment (ART) Analytes Bictegravir (BIC), Dolutegravir (DTG), and Darunavir (DRV) Trough Concentrations (Ctrough) in Plasma at Each Received Dose of Oral 17-β Estradiol

Timeframe: Study Entry and Weeks 4, 12, 24, 36, and 48

Percentage of Participants With ART Analyte Trough Concentration (Ctrough) Above Drug-specific Threshold

Timeframe: Study Entry and Weeks 4, 12, 24, 36, and 48

Trough Serum Total Estradiol Assessed at Each Received Dose of Oral 17-β Estradiol as Quantified Via Batch Testing at Central Lab.

Timeframe: Study Entry and Weeks 4, 12, 24, 36, and 48

Trial details

NCT IDNCT06005610

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-08-21

Results submitted2025-12-30

View on ClinicalTrials.gov More HIV I Infection trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Documentation of HIV-1 status.
✓. On ART for at least 24 weeks prior to study entry. Regimen changes within the 24 weeks prior to study entry are acceptable, but candidates must have been on a stable regimen for at least 28 days prior to study entry.
✓. On BIC/FTC/TAF, DTG/TDF/FTC or 3TC, or DRV/c-containing ART for at least 28 days prior to study entry (single tablet regimen not required), and with no plans to change ART regimen over the study duration of 48 weeks.
✓. Desire to initiate or restart FHT, regardless of orchiectomy status.
✓. HIV-1 RNA \<200 copies/mL at screening.
✓. HIV-1 RNA \<400 copies/mL available through routine clinical care between 24 and 96 weeks prior to study entry and while on ART. The HIV-1 RNA must be the most recent value obtained between 24 and 96 weeks prior to study entry.
✓. The following laboratory values obtained within 60 days prior to study entry
✓. Serum estradiol level \<75 pg/mL within 60 days prior to study entry.

Exclusion criteria

What they're measuring

Timeframe: Study Entry and Weeks 4, 12, 24, 36, and 48

Percentage of Participants With ART Analyte Trough Concentration (Ctrough) Above Drug-specific Threshold

Timeframe: Study Entry and Weeks 4, 12, 24, 36, and 48

Trough Serum Total Estradiol Assessed at Each Received Dose of Oral 17-β Estradiol as Quantified Via Batch Testing at Central Lab.

Timeframe: Study Entry and Weeks 4, 12, 24, 36, and 48