HIV I InfectionPhase 4DYADNCT04585737
Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF
A Phase 4 study testing Dolutegravir / Lamivudine Pill and Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill in people with HIV I Infection, run by Charlotte-Paige Rolle, MD at 1 site in United States.
Trial summary
Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV I Infection
- What is being tested?
- Dolutegravir / Lamivudine Pill and Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 10 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older at the time of signing the informed consent
- TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- HIV-1 infected men or women.
- Must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
- Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL at least 3 months apart prior to Day 1 (the screening HIV-1 RNA can count as the second measurement)
- Plasma HIV-1 RNA <50 c/mL at Screening.
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- Must be on uninterrupted B/F/TAF for at least 3 months prior to screening
- SEX
- Male or female A female subject is eligible to participate if she is not pregnant [as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Day
- 1/Randomization (a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization)], not lactating, and at least one of the following conditions applies:
- Non-reproductive potential defined as:
- Pre-menopausal females with one of the following:
- o Documented tubal ligation
- Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- Hysterectomy
- Documented Bilateral Oophorectomy
- Post-menopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
- Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Appendix 2) from 30 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication.
- The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. All subjects participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.
- INFORMED CONSENT
- 8. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible subjects must sign a written Informed Consent Form before any protocol-specified assessments are conducted
- Exclusion Criteria
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Who cannot join
- CONCURRENT CONDITIONS/MEDICAL HISTORY
- Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
- Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease [15], EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/mm3 are NOT exclusionary.
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification [16].
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
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- Subjects positive for HBsAg are excluded.
- Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
- Note: Subjects positive for anti-HBc (negative HBsAg status) and positive for antiHBs (past and/or current evidence) are immune to HBV and are not excluded. AntiHBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM.
- Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study
- Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Subjects who are at least 7 days post completed treatment are eligible.
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
- Subjects who in the investigator's judgment, poses a significant suicidality risk.
- EXCLUSIONARY TREATMENTS PRIOR TO SCREENING OR DAY 1
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with any of the following agents within 28 days of Screening
- radiation therapy
- cytotoxic chemotherapeutic agents
- any systemic immune suppressant
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study medication.
- Use of any regimen consisting of single or dual ART LABORATORY VALUES OR CLINICAL ASSESSMENTS AT SCREENING
- Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result
- Any verified Grade 4 laboratory abnormality
- Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN) or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin).
- Creatinine clearance of <50mL/min/1.73m2 via CKD-EPI method.
- EXCLUSIONARY CRITERIA PRIOR TO SCREENING OR DAY 1
- Within the 6 to 12-month window prior to Screening and after confirmed suppression to <50 copies/mL, any plasma HIV-1 RNA measurement >200 c/mL.
- Within the 6 to 12-month window prior to Screening and after confirmed suppression to <50 copies/mL, 2 or more plasma HIV-1 RNA measurements ≥50 c/mL.
- Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement ≥50 copies/mL.
- Any drug holiday during the 12 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
- Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA ≥400 copies/mL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study
Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
Read the detailed description
Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV
Participants who provide written informed consent and meet all the eligibility criteria will be randomized in a 2:1 ratio to one of the following 2 treatment groups:
Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.
Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food.
Randomization will be stratified by gender and race at entry given that this study aims to enroll at least 30% of participants who are female and African American.
All participants will be responsible for using their insurance plan to obtain coverage for DTG/3TC and or B/F/TAF, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs.
Study duration will be 48 weeks.
Number of participants planned: Approximately 222 participants
Target Population: HIV-1 infected adult participants who are virologically suppressed (HIV-1 RNA<50 copies/mL) on FDC of B/F/TAF (50mg/200mg/ 25mg) ≥ 3 months prior to screening
- Conditions
- HIV I Infection
- Being tested
- Dolutegravir / Lamivudine Pill, Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill
- Keywords
- switch study, dovato, biktarvy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir / Lamivudine PillDrug
Also called Dovato
Experimental
Bictegravir / Emtricitabine / Tenofovir Alafenamide PillDrug
Also called Biktarvy
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Receives: Drug: Dolutegravir / Lamivudine Pill |
| Treatment group 2 | Active comparator | Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Receives: Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure is to Evaluate the Efficacy of Switching From B/F/TAF to DTG/3TC Versus Continuing B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48
percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm
Measured: 48 weeks
Secondary outcomes (9)
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA≥ 50 Copies/mL at Week 24
percentage with HIV-1 RNA ≥50 copies/mL at Week 24 in each treatment arm
Measured: 24 weeks
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA<50 Copies/mL at Week 48
percentage with HIV-1 RNA<50 copies/mL at Weeks 12, 24 and 48 in each treatment arm
Measured: 48 weeks
The Secondary Outcome Measure is to Measure the Incidence and Severity of Grade 2-5 Drug-related Adverse Events and Laboratory Abnormalities (Graded Using DAIDs Grading Scale) Through 48 Weeks
Grade 2-5 drug-related AEs and lab abnormalities graded using DAIDS grading scale
Measured: 48 weeks
The Secondary Outcome Measure is to Evaluate the Proportion of Participants That Discontinue Treatment Through 48 Weeks in Each Treatment Arm and Reasons for Discontinuation
Number of participants who discontinue study treatment and reasons for discontinuation
Measured: 48 weeks
The Secondary Outcome Measure is to Evaluate the Effects of DTG/3TC Once Daily on Fasting Total Cholesterol Over Time Compared to B/F/TAF Through 48 Weeks
Change from Baseline in fasting total cholesterol at Week 48
Measured: 48 weeks
The Secondary Outcome Measure is to Evaluate Changes in Weight (kg) in Those Treated With DTG/3TC vs. B/F/TAF Over Time
Change from Baseline in weight (kg) measured at Week 48
Measured: 48 weeks
The Secondary Outcome Measure is to Evaluate Changes in Waist Circumference (Inches) in Those Treated With DTG/3TC vs. B/F/TAF Over Time
Change from Baseline in waist circumference (measured in inches) at Week 48
Measured: 48 weeks
The Secondary Outcome Measure is to Evaluate Changes in BMI (kg/m2) in Those Treated With DTG/3TC vs. B/F/TAF Over Time
Change from Baseline in weight (kg) and height (meters) will be used to assess changes in BMI (kg/m2) measured at Week 48
Measured: 48 weeks
To Assess the Number of Subjects With Genotypic Mutations Affecting Any Component of the Treatment Regimen Among Subjects Meeting Virologic Rebound Criteria (HIV-1 RNA≥50 Copies/mL X2) Using HIV Genotypic and ARCHIVE HIV-DNA Testing
to measure the incidence of observed genotypic resistance to ARVs for subjects meeting Virologic Rebound Criteria
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start5 Oct 2020
- Primary completion3 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charlotte-Paige Rolle, MD
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor-investigator, Charlotte-Paige Rolle, MD, Orlando Immunology Center
- Investigators
- Charlotte-Paige Rolle, MD, Principal investigator, Orlando Immunology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585737
- Sponsor's protocol ID
- OIC 008
- Acronym
- DYAD
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2020
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study
- ClinicalTrials.gov ID
- NCT04585737
- Acronym / sponsor ID
- DYAD / OIC 008
- Conditions
- HIV I Infection
- Keywords
- switch study, dovato, biktarvy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Charlotte-Paige Rolle, MDUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
Detailed description
Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV
Participants who provide written informed consent and meet all the eligibility criteria will be randomized in a 2:1 ratio to one of the following 2 treatment groups:
Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.
Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food.
Randomization will be stratified by gender and race at entry given that this study aims to enroll at least 30% of participants who are female and African American.
All participants will be responsible for using their insurance plan to obtain coverage for DTG/3TC and or B/F/TAF, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs.
Study duration will be 48 weeks.
Number of participants planned: Approximately 222 participants
Target Population: HIV-1 infected adult participants who are virologically suppressed (HIV-1 RNA<50 copies/mL) on FDC of B/F/TAF (50mg/200mg/ 25mg) ≥ 3 months prior to screening
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: Dolutegravir / Lamivudine PillTreatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. |
| Treatment group 2 | Active comparator | Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide PillTreatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Aged 18 years or older at the time of signing the informed consent
- TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- HIV-1 infected men or women.
- Must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
- Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL at least 3 months apart prior to Day 1 (the screening HIV-1 RNA can count as the second measurement)
Key exclusion criteria (32 listed)
- CONCURRENT CONDITIONS/MEDICAL HISTORY
- Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
- Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease [15], EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/mm3 are NOT exclusionary.
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification [16].
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 |
|---|---|---|
| Dolutegravir / Lamivudine PillAlso: DovatoExperimental | Drug | Treatment group 1 |
| Bictegravir / Emtricitabine / Tenofovir Alafenamide PillAlso: BiktarvyActive comparator | Drug | Treatment group 2 |
Primary outcome
The Primary Outcome Measure is to Evaluate the Efficacy of Switching From B/F/TAF to DTG/3TC Versus Continuing B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48
Time frame: 48 weeks
percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm
9 secondary outcomes
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA≥ 50 Copies/mL at Week 24
Time frame: 24 weeks
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA<50 Copies/mL at Week 48
Time frame: 48 weeks
The Secondary Outcome Measure is to Measure the Incidence and Severity of Grade 2-5 Drug-related Adverse Events and Laboratory Abnormalities (Graded Using DAIDs Grading Scale) Through 48 Weeks
Time frame: 48 weeks
The Secondary Outcome Measure is to Evaluate the Proportion of Participants That Discontinue Treatment Through 48 Weeks in Each Treatment Arm and Reasons for Discontinuation
Time frame: 48 weeks
The Secondary Outcome Measure is to Evaluate the Effects of DTG/3TC Once Daily on Fasting Total Cholesterol Over Time Compared to B/F/TAF Through 48 Weeks
Time frame: 48 weeks
The Secondary Outcome Measure is to Evaluate Changes in Weight (kg) in Those Treated With DTG/3TC vs. B/F/TAF Over Time
Time frame: 48 weeks
The Secondary Outcome Measure is to Evaluate Changes in Waist Circumference (Inches) in Those Treated With DTG/3TC vs. B/F/TAF Over Time
Time frame: 48 weeks
The Secondary Outcome Measure is to Evaluate Changes in BMI (kg/m2) in Those Treated With DTG/3TC vs. B/F/TAF Over Time
Time frame: 48 weeks
To Assess the Number of Subjects With Genotypic Mutations Affecting Any Component of the Treatment Regimen Among Subjects Meeting Virologic Rebound Criteria (HIV-1 RNA≥50 Copies/mL X2) Using HIV Genotypic and ARCHIVE HIV-DNA Testing
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Charlotte-Paige Rolle, MD principal investigator
Orlando Immunology Center
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 Dolutegravir / Lamivudine Pill and Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill in people with HIV I Infection, run by Charlotte-Paige Rolle, MD 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 24 inclusion and 32 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: finished, as of the sponsor's last update on 17 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome Measure is to Evaluate the Efficacy of Switching From B/F/TAF to DTG/3TC Versus Continuing B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2024.