HivPhase 4TAF4TRANSNCT04616963
Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis
A Phase 4 study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg and Emtricitabine Tenofovir Alafenamide 200/25 mg in people with Hiv and Hormone Therapy, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Hormone Therapy
- What is being tested?
- Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg and Emtricitabine Tenofovir Alafenamide 200/25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Transgender or non-binary, defined as identifying with a gender differently from sex assigned at birth
- Age 18 years or older
- Currently eligible to take F/TDF for PrEP and willing to switch to F/TAF
- Negative for HIV infection
- Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula in the past 30 days
Who cannot join
- Unable to give informed consent
- Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)
- Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by
- gastrointestinal condition that would impair absorption of study drugs
- known condition of reduced bone density (e.g. osteoporosis or osteogenesis imperfect) that significantly elevate the risk of bone fracture
- neurological or severe psychiatric condition that would significantly impair the ability to adhere to PrEP
Show all 33Show fewer
- tubular or glomerular kidney disease that could be exacerbated by tenofovir
- other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP
- Suspected sensitivity or allergy to the study drug or any of its components
- Currently using an essential product or medication that interacts with the study drug such as the following:
- other antiretroviral agent other than F/TDF (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors or investigational antiretroviral agents)
- agents with known nephrotoxic potential:
- aminoglycoside antibiotics (including gentamicin)
- IV amphotericin B
- cidofovir
- cisplatin
- foscarnet
- IV pentamidine
- IV vancomycin
- oral or IV gancyclovir
- other agents with significant nephrotoxic potential
- drugs that slow renal excretion
- probenecid
- immune system modulators
- systemic chemotherapeutic agents (i.e. cancer treatment medications)
- ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).
- interleukin-2 (IL-2)
- interferon (alpha, beta, or gamma)
- other agent known to have a significant interaction with TDF, TAF, or FTC
- the following table includes medications/herbal supplements to be excluded or should be used with caution while participants are taking study drugs due to potential drug-drug interactions with F/TAF.
- Proteinuria 2+ or greater by urine dipstick
- Pregnancy (if applicable)
- Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103
About this study
Official title: F/TAF Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis (TAF4TRANS)
The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.
Read the detailed description
This is a two-phased prospective switch study of 60 transgender individuals who are eligible for Truvada® (Emtricitabine/Tenofovir Disoproxil Fumarate) F/TDF PrEP and who are willing to switch to Descovy® (Emtricitabine/Tenofovir Alafenamide) F/TAF for 48 weeks. The purpose of the current study is to contribute safety and efficacy data to support the use of F/TAF in transgender/non-binary individuals. The current study leverages existing studies in trans/non-binary populations (e.g. CCTG 603; HRPP#161807) funded by the California HIV/AIDS Research Program (CHRP).
The dosage for Phase I is FTC 200 mg / TDF 300 mg. The dosage for Phase II is FTC 200 mg / TAF 25 mg. TDF/FTC is FDA approved for use as PrEP in adults and adolescents at risk for HIV-1. F/TAF has received approval by the FDA for use as PrEP as of October 3rd, 2019 except for those having receptive vaginal sex. The FDA has yet to approve F/TAF for use in those having receptive vaginal sex due to a lack of clinical research studies specific to the population. Participants will be advised that if they decide to have receptive vaginal sex while taking F/TAF, they should use another method of protection such as condoms.Eligibility criteria will be based on the CDC guidance for PrEP use in transgender persons. All participants must be confirmed HIV-negative (either by rapid test or Ag/Ab test), must have acceptable safety laboratory values, and must currently be taking or will initiate F/TDF by the Screening/Baseline visit. Participants will have a 12-week lead-in period prior to switching to F/TAF. At the Switch Visit, participants will be instructed to substitute F/TDF with F/TAF for PrEP for 48 weeks. Regular follow-up evaluations will occur at Weeks 12, 24, 36, and 48.
Participants will receive health education, clinical assessments, laboratory safety monitoring, STI and HIV screening, standard HIV risk reduction and adherence counseling, assessment of psychosocial barriers, and completion of a computer-based self-report survey that includes assessments of adherence and risk behaviors. Intracellular TFV-DP quantification will be performed in retrospect on batched, banked samples and additional banked specimens will be frozen for future use. Adherence by TFV-DP concentrations and self-reported measures will be used for the primary and secondary analyses of the study. Additional outcomes for the study will include changes in risk behavior and determinants of PrEP adherence.
This study will continue iTAB, a daily text message support system for adherence up until 12 weeks after F/TAF switch. As needed, the study will provide a) subject reimbursement to pay for unlimited text messaging and/or b) an appropriate cell phone if a subject does not have one. Daily dosing text message reminders will be sent for the duration of the study. Both reminder timing and content can be individualized. Participants have selected 15 personal reminders from a list of pre-determined reminders that cover various themes shown to be effective in improving adherence (e.g., social support, loss frame, health gain, etc.) as developed through focus groups and targeted group feedback. These messages can be modified and the patient can choose to create their own reminders if they prefer. These reminder times can vary for different days of the week to accommodate for changes in schedule (e.g., 8 M-F, and 10 AM on Sat/Sun). Once the time is identified, the text reminder system is automated. Patients will confirm medication taking via text responses to the personalized reminders.
- Conditions
- Hiv, Hormone Therapy
- Being tested
- Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg, Emtricitabine Tenofovir Alafenamide 200/25 mg
- Keywords
- Pre-exposure Prophylaxis, PrEP, Hormone Therapy, HT
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mgDrug
Also called Truvada 200Mg-300Mg Tablet
Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.
Emtricitabine Tenofovir Alafenamide 200/25 mgDrug
Also called Descovy 200Mg-25Mg Tablet
Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation
| Study group | Role | What they receive |
|---|---|---|
| FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg | Other | Phase I: Participants will continue or initiate F/TDF for PrEP for a minimum 12-week lead-in period prior to switching to F/TAF.
Phase II: Participants will be switched to study-provided F/TAF for PrEP until 48 weeks after initiation. Participants will receive study treatment for the duration of the study unless they meet criteria for discontinuation. Receives: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg; Drug: Emtricitabine Tenofovir Alafenamide 200/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring tenofovir diphosphate (TFV-DP) concentrations
Analysis will be performed on the primary outcome of TFV-DP levels by HT status. Comparison of those on and off HT will be done be t-test. Additional sub-analysis of the primary will stratify by HT type and using both concentrations of TFV-DP and estradiol levels test for correlation. Also cut offs for adherence consistent with 4 doses a week and 7 doses a week will be compared between strata.
Measured: Baseline-48 weeks
Secondary outcomes (5)
Evaluating safety of F/TAF in transgender individuals compared to F/TDF: adverse events
Safety data will be reported for all participants during use of study drug and immediately after (30 days) completion (as treated analysis). Tables will summarize the number of serious adverse events, adverse events (Grade 1 or higher) over 48 weeks, and PrEP discontinuation due to adverse events.
Measured: Baseline-48 weeks
Evaluating tolerability of F/TAF in transgender individuals compared to F/TDF.
Tolerability will be assessed using Likert scales for those that found favorable tolerability and greater between week 12 F/TDF and week 12 F/TAF.
The Likert scale uses answers on a range of:
- Strongly agree (maximum)
- Agree
- Neutral
- Disagree
- Strongly Disagree (minimum)
A higher score (strongly agree) would indicate a better outcome for Descovy compared to Truvada.
Measured: Baseline-48 weeks
Adherence to F/TAF in transgender individuals compared to F/TDF
Adherence will be assessed by comparing TFV-DP concentrations commensurate with i) 7 doses/week and ii) 4 doses/week; iii) TFV-DP levels as a continuous measure; and iv) self-reported adherence by text message over 48 weeks between participants on F/TDF versus participants on F/TAF
Measured: Baseline-48 weeks
Evaluating serum creatinine between F/TDF and F/TAF.
Serum creatinine concentrations will be compared between Week 12 of F/TDF and Week 12 on F/TAF.
Measured: Week 12
Evaluating calculated creatinine clearance between F/TDF and F/TAF.
Calculated creatinine clearance will be compared between Week 12 of F/TDF and Week 12 on F/TAF.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start24 Oct 2019
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheldon Morris, University of California, San Diego
- Investigators
- Sheldon Morris, MD, Principal investigator, UC San Diego AntiViral Research Center (AVRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616963
- Sponsor's protocol ID
- CCTG 605
- Acronym
- TAF4TRANS
- Status last verified
- May 2023
- First submitted
- 13 Jul 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Patel N, Awdishu L, Burke LB, Vaingankar S, Chow K, Pacheco D, Silva J, Higgins N, Muttera L, Blumenthal J, Morris S. Comparison of Existing and New Race- and Sex-Free Kidney Function Equations in Transgender Adults without CKD. Clin J Am Soc Nephrol. 2025 Jul 22;20(9):1280-1282. doi: 10.2215/CJN.0000000688. No abstract available.
PubMed 40694414
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F/TAF Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis (TAF4TRANS)
- ClinicalTrials.gov ID
- NCT04616963
- Acronym / sponsor ID
- TAF4TRANS / CCTG 605
- Conditions
- Hiv, Hormone Therapy
- Keywords
- Pre-exposure Prophylaxis, PrEP, Hormone Therapy, HT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.
Detailed description
This is a two-phased prospective switch study of 60 transgender individuals who are eligible for Truvada® (Emtricitabine/Tenofovir Disoproxil Fumarate) F/TDF PrEP and who are willing to switch to Descovy® (Emtricitabine/Tenofovir Alafenamide) F/TAF for 48 weeks. The purpose of the current study is to contribute safety and efficacy data to support the use of F/TAF in transgender/non-binary individuals. The current study leverages existing studies in trans/non-binary populations (e.g. CCTG 603; HRPP#161807) funded by the California HIV/AIDS Research Program (CHRP).
The dosage for Phase I is FTC 200 mg / TDF 300 mg. The dosage for Phase II is FTC 200 mg / TAF 25 mg. TDF/FTC is FDA approved for use as PrEP in adults and adolescents at risk for HIV-1. F/TAF has received approval by the FDA for use as PrEP as of October 3rd, 2019 except for those having receptive vaginal sex. The FDA has yet to approve F/TAF for use in those having receptive vaginal sex due to a lack of clinical research studies specific to the population. Participants will be advised that if they decide to have receptive vaginal sex while taking F/TAF, they should use another method of protection such as condoms.Eligibility criteria will be based on the CDC guidance for PrEP use in transgender persons. All participants must be confirmed HIV-negative (either by rapid test or Ag/Ab test), must have acceptable safety laboratory values, and must currently be taking or will initiate F/TDF by the Screening/Baseline visit. Participants will have a 12-week lead-in period prior to switching to F/TAF. At the Switch Visit, participants will be instructed to substitute F/TDF with F/TAF for PrEP for 48 weeks. Regular follow-up evaluations will occur at Weeks 12, 24, 36, and 48.
Participants will receive health education, clinical assessments, laboratory safety monitoring, STI and HIV screening, standard HIV risk reduction and adherence counseling, assessment of psychosocial barriers, and completion of a computer-based self-report survey that includes assessments of adherence and risk behaviors. Intracellular TFV-DP quantification will be performed in retrospect on batched, banked samples and additional banked specimens will be frozen for future use. Adherence by TFV-DP concentrations and self-reported measures will be used for the primary and secondary analyses of the study. Additional outcomes for the study will include changes in risk behavior and determinants of PrEP adherence.
This study will continue iTAB, a daily text message support system for adherence up until 12 weeks after F/TAF switch. As needed, the study will provide a) subject reimbursement to pay for unlimited text messaging and/or b) an appropriate cell phone if a subject does not have one. Daily dosing text message reminders will be sent for the duration of the study. Both reminder timing and content can be individualized. Participants have selected 15 personal reminders from a list of pre-determined reminders that cover various themes shown to be effective in improving adherence (e.g., social support, loss frame, health gain, etc.) as developed through focus groups and targeted group feedback. These messages can be modified and the patient can choose to create their own reminders if they prefer. These reminder times can vary for different days of the week to accommodate for changes in schedule (e.g., 8 M-F, and 10 AM on Sat/Sun). Once the time is identified, the text reminder system is automated. Patients will confirm medication taking via text responses to the personalized reminders.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.
| Arm | Type | Receives |
|---|---|---|
| FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg | Other | Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg, Drug: Emtricitabine Tenofovir Alafenamide 200/25 mgPhase I: Participants will continue or initiate F/TDF for PrEP for a minimum 12-week lead-in period prior to switching to F/TAF. Phase II: Participants will be switched to study-provided F/TAF for PrEP until 48 weeks after initiation. Participants will receive study treatment for the duration of the study unless they meet criteria for discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Transgender or non-binary, defined as identifying with a gender differently from sex assigned at birth
- Age 18 years or older
- Currently eligible to take F/TDF for PrEP and willing to switch to F/TAF
- Negative for HIV infection
- Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula in the past 30 days
Key exclusion criteria (33 listed)
- Unable to give informed consent
- Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)
- Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by
- Suspected sensitivity or allergy to the study drug or any of its components
- Currently using an essential product or medication that interacts with the study drug such as the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mgAlso: Truvada 200Mg-300Mg TabletFollowing Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation. | Drug | FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg |
| Emtricitabine Tenofovir Alafenamide 200/25 mgAlso: Descovy 200Mg-25Mg TabletFollowing Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation | Drug | FTC 200 mg / TDF 300 mg and FTC 200 mg / TAF 25 mg |
Primary outcome
Measuring tenofovir diphosphate (TFV-DP) concentrations
Time frame: Baseline-48 weeks
Analysis will be performed on the primary outcome of TFV-DP levels by HT status. Comparison of those on and off HT will be done be t-test. Additional sub-analysis of the primary will stratify by HT type and using both concentrations of TFV-DP and estradiol levels test for correlation. Also cut offs for adherence consistent with 4 doses a week and 7 doses a week will be compared between strata.
5 secondary outcomes
Evaluating safety of F/TAF in transgender individuals compared to F/TDF: adverse events
Time frame: Baseline-48 weeks
Evaluating tolerability of F/TAF in transgender individuals compared to F/TDF.
Time frame: Baseline-48 weeks
Adherence to F/TAF in transgender individuals compared to F/TDF
Time frame: Baseline-48 weeks
Evaluating serum creatinine between F/TDF and F/TAF.
Time frame: Week 12
Evaluating calculated creatinine clearance between F/TDF and F/TAF.
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 40694414Patel N, Awdishu L, Burke LB, Vaingankar S, Chow K, Pacheco D, Silva J, Higgins N, Muttera L, Blumenthal J, Morris S. Comparison of Existing and New Race- and Sex-Free Kidney Function Equations in Transgender Adults without CKD. Clin J Am Soc Nephrol. 2025 Jul 22;20(9):1280-1282. doi: 10.2215/CJN.0000000688. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Morris, MD principal investigator
UC San Diego AntiViral Research Center (AVRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg and Emtricitabine Tenofovir Alafenamide 200/25 mg in people with Hiv and Hormone Therapy, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring tenofovir diphosphate (TFV-DP) concentrations (time frame: Baseline-48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.