Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

Trial on Estradiol and HIV Therapy in Transgender Women Terminated

NCT: NCT06005610 · Status: TERMINATED · Phase: Phase 2 · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · Started: 2024-01-04 · Est. Completion: 2025-08-21

Plain English Summary

Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy is a Phase 2 clinical trial sponsored by National Institute of Allergy and Infectious Diseases (NIAID) studying HIV I Infection. This trial investigated how standard estradiol therapy (feminizing hormones) interacts with HIV medications in transgender women living with HIV. It was designed for transgender women living with HIV who were already on HIV treatment and wanted to start or restart feminizing hormone therapy. Participants received study-provided estradiol for up to 48 weeks, and their HIV medication levels were monitored. The trial was terminated early and did not complete its planned enrollment or duration. The trial aims to enroll 93 participants.

Official 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

Here is what you need to know about eligibility for this trial. Adults assigned male at birth who identify as female or transfeminine and are living with HIV. Must be on a stable HIV treatment regimen for at least 28 days before starting the study. Must have well-controlled HIV (viral load below 200 copies/mL) and specific lab values within normal ranges. Cannot have a history of blood clots, liver problems, certain hepatitis infections, or breast cancer. This trial is studying HIV I Infection, so participants generally need a confirmed diagnosis.

What They're Measuring

The study measured whether HIV medications remained at effective levels in the blood while participants took estradiol, ensuring their HIV treatment continued to work. The specific primary outcome measures are: 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 (Study Entry and Weeks 4, 12, 24, 36, and 48); Percentage of Participants With ART Analyte Trough Concentration (Ctrough) Above Drug-specific Threshold (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. (Study Entry and Weeks 4, 12, 24, 36, and 48). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aimed to address concerns about potential interactions between feminizing hormone therapy and HIV medications, which is crucial for ensuring effective HIV treatment and well-being in transg Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets HIV I Infection, where improved treatment options are needed.

Investor Insight

The termination of this trial suggests potential challenges in recruitment or unforeseen issues, impacting the development of evidence-based guidance for this specific patient population and potential Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific HIV medications you are taking and if they have known interactions with hormone therapy. Discuss any concerns you have about starting or continuing hormone therapy alongside your HIV treatment. Understand that this trial was terminated, meaning it did not provide all the intended data. The trial is being conducted at 18 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

1. Documentation of HIV-1 status.
2. 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.
3. 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.
4. Desire to initiate or restart FHT, regardless of orchiectomy status.
5. HIV-1 RNA \<200 copies/mL at screening.
6. 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.
7. The following laboratory values obtained within 60 days prior to study entry

   * Hemoglobin ≥9.0 g/dL
   * Platelet count ≥75,000/mm3
   * Estimated Glomerular Filtration Rate (eGFR) ≥30 mL/min/1.73m2 if on or switching to TAF, ≥50 mL/min/1.73m2 if on or switching to TDF without cobicistat, or ≥70 mL/min/1.73m2 if on or switching to TDF in combination with cobicistat, calculated using standardized equation for eGFR
   * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase are within normal range per local laboratory range
   * Prolactin \<25 ng/dL
8. Serum estradiol level \<75 pg/mL within 60 days prior to study entry.
9. Willingness to avoid the use of prescribed, non-study provided FHT and non-prescribed FHT during the study period, and no planned use of prescribed or non-prescribed anti-androgens for the first 24 weeks of the study.
10. Ability and willingness of participant to provide informed consent and ability and willingness of participant to undergo study procedures.

Exclusion Criteria:

1. Known clotting disorders, active deep vein thrombosis (DVT), pulmonary embolism (PE), or history of these conditions, active arterial thromboembolic disease (e.g., stroke, myocardial infarction), or history of these conditions.
2. Known liver impairment or disease.
3. History of chronic hepatitis B virus (HBV) infection or active HBV infection.
4. History of current active hepatitis C virus (HCV) infection.
5. Prohibited medication use (including drugs with known or expected DDIs with FHT or ART) at time of study entry.
6. Receipt of any estrogen therapy within 14 days prior to study entry for persons on oral FHT, or within 30 days prior to entry for persons on injectable FHT.
7. Known HIV-1 resistance mutations that would preclude remaining on current ART or a switch to a study regimen, in the opinion of the site investigator.
8. Personal history of breast cancer. or known personal history of breast cancer (BRCA) gene.
9. Known or a history of testicular cancer.
10. Known or a history of gall bladder disease.
11. Known or suspected pituitary adenoma.
12. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
13. Suicidal ideation in the past 30 days or suicide attempt in the past 90 days, as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS).
14. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry. Stable (in the opinion of the site investigator) treatments for chronic comorbidities are allowed.
15. Presence of any other medical condition that would preclude FHT administration for safety reasons, in the opinion of the site investigator.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06005610?

NCT06005610 is a Phase 2 INTERVENTIONAL study titled "Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy." It is currently terminated and is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The trial targets enrollment of 93 participants.

What conditions does NCT06005610 study?

This trial investigates treatments for HIV I Infection. The primary condition under study is HIV I Infection.

What treatments are being tested in NCT06005610?

The interventions being studied include: Estradiol (DRUG). Oral 17-β estradiol 2 mg once daily initiated immediately following entry. At weeks 4, 12, 24, and 36, study clinicians may have titrated 17-β estradiol in 2 mg increments to achieve the desired participant goals and target hormone concentrations, as measured locally at each visit.

What does Phase 2 mean for NCT06005610?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06005610?

This trial is currently "Terminated." It started on 2024-01-04. The estimated completion date is 2025-08-21.

Who is sponsoring NCT06005610?

NCT06005610 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06005610?

The trial aims to enroll 93 participants. The trial status is terminated.

How is NCT06005610 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06005610?

The primary outcome measures are: 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 (Study Entry and Weeks 4, 12, 24, 36, and 48); Percentage of Participants With ART Analyte Trough Concentration (Ctrough) Above Drug-specific Threshold (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. (Study Entry and Weeks 4, 12, 24, 36, and 48). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06005610 being conducted?

This trial is being conducted at 18 sites, including San Diego, California; San Francisco, California; Aurora, Colorado; Washington D.C., District of Columbia and 14 more sites (United States, Mexico, Peru).

Where can I find official information about NCT06005610?

The official record for NCT06005610 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06005610. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06005610 testing in simple terms?

This trial investigated how standard estradiol therapy (feminizing hormones) interacts with HIV medications in transgender women living with HIV. It was designed for transgender women living with HIV who were already on HIV treatment and wanted to start or restart feminizing hormone therapy.

Why is this trial significant?

This trial aimed to address concerns about potential interactions between feminizing hormone therapy and HIV medications, which is crucial for ensuring effective HIV treatment and well-being in transg

What are the potential risks of participating in NCT06005610?

Potential for drug-drug interactions between estradiol and HIV medications, which could affect the effectiveness of either treatment. Risks associated with hormone therapy, such as blood clots, liver issues, or changes in mood, although these were monitored. The trial was terminated, meaning participants did not complete the full study duration, and the full scope of potential long-term effects or interactions may not be known from this specific study. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06005610?

Ask your doctor about the specific HIV medications you are taking and if they have known interactions with hormone therapy. Discuss any concerns you have about starting or continuing hormone therapy alongside your HIV treatment. Understand that this trial was terminated, meaning it did not provide all the intended data. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06005610 signal from an investment perspective?

The termination of this trial suggests potential challenges in recruitment or unforeseen issues, impacting the development of evidence-based guidance for this specific patient population and potential This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants received study-provided estradiol for up to 48 weeks, and their HIV medication levels were monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.