(mo)BETTA Trial in Transwomen for Optimization of ART
Study Details
Study Description
Brief 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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Switch ART Switch from current antiretroviral therapy (ART) to B/FTC/TAF bfor 48 weeks |
Drug: B/FTC/TAF
B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
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Active Comparator: Continue Current ART Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks |
Drug: Current ART
Comparator arm. Participant continues open label entry ART.
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Outcome Measures
Primary Outcome Measures
- Frequency of Maintaining Undetectable HIV-1 RNA [48 weeks]
Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks
- Frequency of Adverse Events [48 weeks]
Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events)
Secondary Outcome Measures
- Lean mass [48 weeks]
Change in lean mass (total, limb) as measured by Dual-energy X-ray absorptiometry (DXA)
- Fat Mass [48 weeks]
Change in fat mass (total, trunk, limb) as measured by DXA
- Bone Mineral Density (BMD) [48 weeks]
Change in BMD as measured by DXA
- Hepatic Fat Content [48 weeks]
Change hepatic fat content as measured by FibroScan controlled attenuation parameter (CAP)
- Total cholesterol [48 weeks]
Change in total cholesterol level
- HDL cholesterol [48 weeks]
Change in HDL cholesterol level
- Triglycerides [48 weeks]
Change in Triglyceride level
- LDL cholesterol [48 weeks]
Change in LDL cholesterol
- Insulin level [48 weeks]
Change in Insulin level
- Glucose level [48 weeks]
Change in Glucose level
- Insulin Resistance [48 weeks]
Change in Number of participants with insulin resistance as measured by the homeostatic assessment model of insulin resistance (HOMA-IR)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Self-identified transgender woman (TW)
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HIV infection
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Undetectable HIV viral load (HIV-1 RNA <50 copies/mL) at screening and for >/=24 weeks prior to entry.
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Current HIV treatment with FTC plus TDF or TAF and a 3rd agent.
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No changes in ART in the 12 weeks prior to screening.
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Current female hormone therapy use.
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Ability and willingness of subject to provide informed consent.
Exclusion Criteria:
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Current or planned use of prohibited medications (Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea, Dofetilide, Cisapride, Atazanavir)
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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.
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Current use of androgen therapy.
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Intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period.
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Anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period.
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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)
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Current use of bictegravir in another investigational setting
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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)
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Any condition that the study investigator believes would make the candidate unsuitable for participation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Thomas Street Health Center | Houston | Texas | United States | 77009 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- Gilead Sciences
Investigators
- Principal Investigator: Jordan E Lake, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-17-0480