HIV InfectionsPhase 4(mo)BETTANCT03348163
(mo)BETTA Trial in Transwomen for Optimization of ART
A Phase 4 study testing B/FTC/TAF and Current ART in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- B/FTC/TAF and Current ART
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 15 Dec 2020
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified transgender woman (TW)
- HIV infection
- Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks prior to entry.
- Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.
- No changes in ART in the 12 weeks prior to screening.
- Current female hormone therapy use.
- Ability and willingness of subject to provide informed consent.
Who cannot join
- Current or planned use of prohibited medications (Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea, Dofetilide, Cisapride, Atazanavir)
- Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period.
- Current use of androgen therapy.
- Intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period.
- Anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period.
- Screening laboratory values as follows: (ANC <500 cells/mm^3; Hemoglobin <10 gm/dL; Cr Cl <30 mL/min (estimated by CKD-Epi equation); AST or ALT >3x ULN)
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- Evidence of resistance to any component of the current ART regimen (genotypic or phenotypic)
- Current use of bictegravir in another investigational setting
- Current use of other investigational agents that the participant could not receive unchanged, if needed, throughout the study period (unless approved by the study team)
- Any condition that the study investigator believes would make the candidate unsuitable for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial
The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW).
- Conditions
- HIV Infections
- Being tested
- B/FTC/TAF, Current ART
- Keywords
- Transgender women, Bictegravir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/FTC/TAFDrug
B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
Current ARTDrug
Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.
| Study group | Role | What they receive |
|---|---|---|
| Switch ART | Experimental | Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks Receives: Drug: B/FTC/TAF |
| Continue Current ART | Active comparator | Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks. Receives: Drug: Current ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Maintaining Undetectable HIV-1 RNA
Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks
Measured: 48 weeks
Frequency of Adverse Events
Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events)
Measured: 48 weeks
Secondary outcomes (76)
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: baseline
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: Baseline
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 48 weeks
Hepatic Fat Content
The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.
Measured: Baseline
Hepatic Fat Content
The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.
Measured: 48 weeks
Total Cholesterol
Total cholesterol level
Measured: Baseline
Total Cholesterol
Total cholesterol level
Measured: 48 weeks
High-density Lipoprotein (HDL) Cholesterol Level
Measured: Baseline
High-density Lipoprotein (HDL) Cholesterol Level
Measured: 48 weeks
Triglycerides
Triglyceride level
Measured: Baseline
Triglycerides
Triglyceride level
Measured: 48 weeks
Low-density Lipoprotein (LDL) Cholesterol Level
Measured: Baseline
Low-density Lipoprotein (LDL) Cholesterol Level
Measured: 48 weeks
Fasting Glucose Level
Fasting Glucose level
Measured: Baseline
Fasting Glucose Level
Fasting Glucose level
Measured: 48 weeks
Insulin Resistance
The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).
Measured: Baseline
Insulin Resistance
The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).
Measured: 48 weeks
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Measured: Baseline
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Measured: 48 weeks
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness
Measured: Baseline
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness
Measured: 48 weeks
Aspartate Aminotransferase (AST) Level
Measured: Baseline
Aspartate Aminotransferase (AST) Level
Measured: 48 weeks
Alanine Transaminase (ALT) Level
Measured: Baseline
Alanine Transaminase (ALT) Level
Measured: 48 weeks
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Measured: Baseline
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Measured: 48 weeks
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Insulin
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Insulin
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of D-dimer
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of D-dimer
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Measured: Baseline
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Measured: 48 weeks
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: Baseline
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: 48 weeks
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: Baseline
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: 48 weeks
T-Score AP-spine L1-L4
Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: Baseline
T-Score AP-spine L1-L4
Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: 48 weeks
T-Score Total Body
Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: Baseline
T-Score Total Body
Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: 48 weeks
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: Baseline
T-Score Femur Total Mean
Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: Baseline
T-Score Femur Total Mean
Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: 48 weeks
T-Score Femur Neck Mean
Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: Baseline
T-Score Femur Neck Mean
Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA)
A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis
Measured: 48 weeks
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: 48 weeks
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Measured: Baseline
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
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 posted20 Nov 2017
- Study start6 Jun 2018
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Why it stopped: Lack of ability to recruit due to COVID-19 pandemic
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 InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Jordan Elizabeth Lake, The University of Texas Health Science Center, Houston
- Investigators
- Jordan E Lake, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348163
- Sponsor's protocol ID
- HSC-MS-17-0480
- Acronym
- (mo)BETTA
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2017
- Last updated
- 3 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial
- ClinicalTrials.gov ID
- NCT03348163
- Acronym / sponsor ID
- (mo)BETTA / HSC-MS-17-0480
- Conditions
- HIV Infections
- Keywords
- Transgender women, Bictegravir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of ability to recruit due to COVID-19 pandemic
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Posted 3 Oct 2022
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 determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch ART | Experimental | Drug: B/FTC/TAFSwitch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks |
| Continue Current ART | Active comparator | Drug: Current ARTContinue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identified transgender woman (TW)
- HIV infection
- Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks prior to entry.
- Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.
- No changes in ART in the 12 weeks prior to screening.
Key exclusion criteria (10 listed)
- Current or planned use of prohibited medications (Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea, Dofetilide, Cisapride, Atazanavir)
- Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period.
- Current use of androgen therapy.
- Intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period.
- Anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period.
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 |
|---|---|---|
| B/FTC/TAFB/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen) | Drug | Switch ART |
| Current ARTCurrent ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent. | Drug | Continue Current ART |
Primary outcome
Frequency of Maintaining Undetectable HIV-1 RNA
Time frame: 48 weeks
Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks
Frequency of Adverse Events
Time frame: 48 weeks
Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events)
76 secondary outcomes
Fat Mass, Total
Time frame: Baseline
Fat Mass, Total
Time frame: 48 weeks
Fat Mass, Trunk
Time frame: Baseline
Fat Mass, Trunk
Time frame: 48 weeks
Fat Mass, Limbs
Time frame: baseline
Fat Mass, Limbs
Time frame: 48 weeks
Percentage of Fat Mass (Total)
Time frame: Baseline
Percentage of Fat Mass (Total)
Time frame: 48 weeks
Percentage of Fat Mass (Trunk)
Time frame: Baseline
Percentage of Fat Mass (Trunk)
Time frame: 48 weeks
Percentage of Fat Mass (Limbs)
Time frame: Baseline
Percentage of Fat Mass (Limbs)
Time frame: 48 weeks
Lean Mass (Total)
Time frame: Baseline
Lean Mass (Limb)
Time frame: Baseline
Lean Mass (Total)
Time frame: 48 weeks
Lean Mass (Limb)
Time frame: 48 weeks
Hepatic Fat Content
Time frame: Baseline
Hepatic Fat Content
Time frame: 48 weeks
Total Cholesterol
Time frame: Baseline
Total Cholesterol
Time frame: 48 weeks
High-density Lipoprotein (HDL) Cholesterol Level
Time frame: Baseline
High-density Lipoprotein (HDL) Cholesterol Level
Time frame: 48 weeks
Triglycerides
Time frame: Baseline
Triglycerides
Time frame: 48 weeks
Low-density Lipoprotein (LDL) Cholesterol Level
Time frame: Baseline
Low-density Lipoprotein (LDL) Cholesterol Level
Time frame: 48 weeks
Fasting Glucose Level
Time frame: Baseline
Fasting Glucose Level
Time frame: 48 weeks
Insulin Resistance
Time frame: Baseline
Insulin Resistance
Time frame: 48 weeks
Oxidized Low-density Lipoprotein (LDL) Level
Time frame: Baseline
Oxidized Low-density Lipoprotein (LDL) Level
Time frame: 48 weeks
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Time frame: Baseline
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement
Time frame: 48 weeks
Aspartate Aminotransferase (AST) Level
Time frame: Baseline
Aspartate Aminotransferase (AST) Level
Time frame: 48 weeks
Alanine Transaminase (ALT) Level
Time frame: Baseline
Alanine Transaminase (ALT) Level
Time frame: 48 weeks
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
Time frame: Baseline
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
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 3 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jordan E Lake, MD principal investigator
The University of Texas Health Science Center, Houston
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 B/FTC/TAF and Current ART in people with HIV Infections, run by The University of Texas Health Science Center, Houston 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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 3 Oct 2022. 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 3 Oct 2022). 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?
Frequency of Maintaining Undetectable HIV-1 RNA (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 3 Oct 2022.