What side effects are associated with this type of intervention?

Common treatments for HIV, such as the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide, are generally well-tolerated but can have side effects. The most frequently reported adverse events include diarrhea and nausea. Serious treatment-related adverse events are rare, and no deaths have been reported in the trials. Long-term data support the safety and durability of these regimens, with no emergent resistance observed. Additionally, these treatments are associated with less renal and bone toxicity compared to older formulations like Tenofovir Disoproxil Fumarate.

What prior FDA approvals exist?

The FDA has approved several antiretroviral therapies for the treatment of HIV, including regimens similar to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF). Notably, Dolutegravir, another integrase strand transfer inhibitor (INSTI), is often combined with Emtricitabine and Tenofovir Alafenamide (D/F/TAF) or with Abacavir and Lamivudine. These combinations are designed to suppress HIV-1 RNA to undetectable levels, similar to the B/F/TAF regimen. Both B/F/TAF and D/F/TAF have shown high efficacy and safety profiles in clinical trials, making them key components in the initial treatment of HIV-1 infection.

What other types of research exist?

One promising alternative to the B/F/TAF regimen for managing HIV is the combination of Dolutegravir, Abacavir, and Lamivudine. This regimen has been shown to be effective and is commonly used as an initial treatment for HIV. Additionally, Dolutegravir-based regimens are known for their high barrier to resistance and favorable safety profile. Another potential alternative is the single-tablet regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide, which has been approved for use in individuals aged 12 years or older and has demonstrated efficacy and safety in virologically suppressed patients. These alternatives may offer effective management of HIV while potentially minimizing drug-drug interactions with feminizing hormones.

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Antiretroviral Combination

Estradiol + Biktarvy for Trans Women Living with HIV (T-DDI Trial)

Phase 4

Waitlist Available

Led By Mona Loutfy, MD, MPH

Research Sponsored by Maple Leaf Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 1, 2 & 6

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial investigates whether common hormone treatments for transgender women interfere with a specific HIV medication. It focuses on transgender women with HIV who are concerned about drug interactions. The study will measure drug and hormone levels in the blood to see if they affect each other.

Who is the study for?

This trial is for trans women living with HIV who are on feminizing hormone therapy and antiretroviral therapy (ART). They must be virally suppressed, willing to adjust their medication schedules, and take a specific ART regimen (B/F/TAF) for the study duration. Participants need to be adults with no relevant ART drug resistance.

What is being tested?

The study investigates how common feminizing hormones used by trans women interact with the HIV treatment B/F/TAF. It compares blood levels of these drugs in trans women taking both treatments against cisgender women on HIV treatment and trans women not infected by HIV.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include changes in hormone levels or interactions affecting the effectiveness of either the hormone therapy or HIV medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 1, 2 & 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 1, 2 & 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 2 & 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2h PBMC and DBS TFV-DP and FTC-TP concentrations.

4 hour serum concentration (C4h) of estradiol

BIC, FTC, and TAF area under the curve (AUC) plasma concentrations.

+5 more

Secondary study objectives

ART adherence using theMedication Adherence Self-Reported Inventory (MASRI)

Baseline estradiol C4h serum concentration and comparison to month 2

Baseline estradiol pre-dose serum concentration (Cmin) and comparison to month 2

+7 more

Other study objectives

Basic sociodemographic variables

Clinical variables

FHT regimens

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Investigational Population (Group 1) - Trans women living with HIVExperimental Treatment2 Interventions

Trans women living with HIV, taking: * Biktarvy * Oral 17(Beta)-Estradiol

Group II: Comparator Population (Group 3) - Trans Women Living without HIVActive Control1 Intervention

Trans women living without HIV, taking: -Oral 17(Beta)-Estradiol

Group III: Comparator Population (Group 2) - Cis Women Living with HIVActive Control1 Intervention

Cis women living with HIV, taking: -Biktarvy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Estradiol Tablets

2019

Completed Early Phase 1

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV, such as the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide, work by targeting different stages of the HIV life cycle. Bictegravir is an integrase strand transfer inhibitor (INSTI) that prevents the viral DNA from integrating into the host cell genome, which is crucial for viral replication. Emtricitabine and Tenofovir Alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs) that inhibit the reverse transcriptase enzyme, blocking the conversion of viral RNA into DNA. This multi-targeted approach is essential for effectively reducing viral load, preventing the progression to AIDS, and improving the overall health and longevity of HIV patients. Additionally, understanding potential drug-drug interactions, such as those with feminizing hormones, is vital for optimizing treatment efficacy and safety in diverse patient populations.

Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial.Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.Efficacy of single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide in the treatment of HIV-1.