Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-24 @ 3:18 PM
NCT ID:
NCT05663892
Eligibility Criteria:
Investigational Population (Group 1) - Trans Women Living with HIV
Inclusion Criteria
1. Is a trans woman or person with transfeminine experience (individual assigned male sex at birth who currently identifies as a woman or person with transfeminine experience and is at any stage of medical, social, or legal transition);
2. Is 18 years of age or older;
3. Is living with HIV;
4. Is currently taking combination ART and has been taking these medications for at least 3 months prior to the screening visit;
5. Is willing to adjust their ART dosing to the morning if they are currently taking it at night for at least 28 days before the baseline visit until the completion of the Month 2 visit;
6. Has had an undetectable viral load for at least 3 months on at least two occasions, where most recent (within 12 months including screening) VL\<40 copies/mL and second (within 24 months) VL\<200 copies/mL with no suggestion of relevant ART drug resistance prior to screening;
7. Is willing to switch to or stay on B/F/TAF for the duration of the study (i.e., 6 months);
8. Is currently taking oral estradiol (2 mg or higher) and an anti-androgen (pharmaceutical \[e.g., spironolactone, cyproterone, finasteride, leuprolide, bicalutamide, dutasteride\] and/or surgical \[orchiectomy\] and/or medical \[hypogonadism\]) and has been taking these medications together at the current dose for at least 3 months prior to the screening visit; AND:
1. Is willing to adjust their oral estradiol dosing to twice a day if they are taking \> 2 mg per day (which is currently recommended as best practice) for at least 28 days before the baseline visit until the completion of the Month 2 visit, with the morning dose set at 2 mg (remaining dose can be taken at night), OR;
2. If their estradiol dosing is 2 mg per day and they are currently taking their estradiol at night, they must be willing to switch their dosing to the morning for at least 28 days before the baseline visit until the completion of the Month 2 visit;
3. Is willing to swallow their oral estradiol if they are currently taking it sublingually or crushing it for at least 28 days before the baseline visit and until the completion of the Month 2 visit;
4. Is willing to keep their anti-androgen (if applicable) medication(s) unchanged until the completion of the Month2 visit;
9. If taking progesterone, is willing to keep the same medication/dose until the completion of the Month 2 visit and must have been taking that dose for at least 3 months prior to the screening visit;
10. Is willing and able to provide full consent for their participation.
Exclusion Criteria
1. Is clinically unable to switch ART to B/F/TAF based on their physician's opinion;
2. Is taking hormonal non-prescription or natural health products in addition to feminizing hormone therapy;
3. Has significant underlying diseases which could worsen due to their participation, or affect their ability to follow the study procedures;
4. Has kidney or liver impairment (ALT \> 5X normal; serum creatinine \[eGFR\] \< 30 mL per minute);
5. Is taking medications known to interact with feminizing hormones, B/F/TAF, or its individual components or has taken such medications within the past 28 days prior to baseline (List of prohibited medications in Appendix B1).
6. Has a known hypersensitivity to bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) or to any ingredient in the formulation.
Comparator Population (Group 2) - Cis Women Living With HIV Inclusion Criteria
1. Is a cis woman (individual assigned female sex at birth who currently identifies as a woman);
2. Is of reproductive age and 18 years of age or older;
3. Is living with HIV;
4. Has a regular period (every 24 - 35 days), or if period is irregular or absent, it is due to the administration of a progesterone only hormone contraceptive (see Appendix B1); or if uterus removed (hysterectomy), ovarie(s) remain functional (FSH level\<27.0 IU/L);
5. Is currently taking combination ART and has been taking these medications for at least 3 months prior to screening;
6. Is willing to adjust their ART dosing to the morning if they are currently taking it at night for at least 28 days before the baseline visit until the completion of the Month 2 visit;
7. Has had an undetectable viral load for at least 3 months on at least two occasions, where most recent (within 12 months including screening) VL\<40 copies/mL and second (within 24 months) VL\<200 copies/mL with no suggestion of relevant ART drug resistance prior to screening;
8. Is willing to switch to or stay on B/F/TAF for the duration of the study (i.e., 6 months);
9. Is willing and able to provide full consent for their participation.
Exclusion Criteria
1. Is clinically unable to switch B/F/TAF based on their physician's opinion;
2. Is pregnant or is planning on getting pregnant for the duration of the study;
3. Has undergone surgery to remove their ovaries (i.e. oophorectomy) or has a condition in which their ovaries produce little or no estrogen (i.e. primary ovarian insufficiency, hypogonadism) or does not have ovaries naturally (i.e. unilateral ovarian absence); total hysterectomy is allowed as long as ovaries are intact and functional;
4. Is taking an estrogen containing or conjugated estrogens hormonal therapies; IUD and progesterone only contraception are allowed (See Appendix B1/2 for list for both prohibited and allowed contraceptives);
5. Has significant underlying diseases which could worsen due to their participation, or affect their ability to follow the study procedures;
6. Has kidney or liver impairment (ALT \> 5X normal; serum creatinine \[eGFR\] \< 30 mL per minute);
7. Has a known hypersensitivity to bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) or to any ingredient in the formulation.
8. Is taking medications known to interact with B/F/TAF, or its individual components or has taken such medications within the past 28 days prior to baseline (List of prohibited medications in Appendix B1/2).
Comparator Population (Group 3) - Trans Women Living Without HIV Inclusion Criteria
1. Is a trans woman or person with transfeminine experience (defined as individual assigned male sex at birth who currently identifies as a woman or person with transfeminine experience irrespective of medical, social, or legal transition);
2. Is 18 years of age or older;
3. Is HIV negative at screening;
4. Is currently taking oral estradiol (2mg or higher) and an anti-androgen (pharmaceutical \[i.e., spironolactone, cyproterone, finasteride, leuprolide, bicalutamide, dutasteride\] and/or surgical \[orchiectomy\] and/or medical \[hypogonadism\]) and has been taking these medications at the current dose for at least 3 months prior to the screening visit, AND:
1. Is willing to adjust their oral estradiol dosing to twice a day if they are taking \> 2 mg per day (which is currently recommended as best practice) for at least 28 days before the baseline visit until the completion of the Month 2 visit, with the morning dose set at 2 mg (remaining dose can be taken at night) OR;
2. If their estradiol dosing is 2 mg per day and they are currently taking their estradiol at night, they must be willing to switch their dosing to the morning for at least 28 days before the baseline visit until the completion of the Month 2 visit;
3. Is willing to swallow their oral estradiol if they are currently taking it sublingually or crushing it for at least 28 days before the baseline visit until the completion of the Month 2 visit;
4. Is willing to keep their anti-androgen (if applicable) medication(s) unchanged until the completion of the Month2 visit;
5. If taking progesterone, is willing to keep their dose the same until the Month 2 visit and must have been taking that dose for at least 3 months prior to the screening visit;
6. Is willing and able to provide full consent for their participation.
Exclusion Criteria
1. Is taking hormonal non-prescription or natural health products in addition to feminizing hormone therapy;
2. Has taken HIV pre-exposure prophylaxis (PrEP) (i.e, TDF/FTC or TAF/FTC) or HIV post-exposure prophylaxis (PEP) in the prior 28 days from baseline and plans to continue during the study;
3. Has significant underlying diseases which could worsen due to their participation, or affect their ability to follow the study procedures;
4. Has kidney or liver impairment (ALT \> 5X normal; serum creatinine \[eGFR\] \< 30 mL per minute);
5. Is taking medications known to interact with feminizing hormones or has taken such medications within the past 28 days prior to baseline (List of prohibited medications in Appendix B1).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05663892
Study Brief:
Protocol Section:
NCT05663892