(mo)BETTA Trial in Transwomen for Optimization of ART

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Terminated
CT.gov ID
NCT03348163
Collaborator
Gilead Sciences (Industry)
26
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2
30.3
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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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bictegravir, Emtricitabine and Tenofovir Alafenamide in Transwomen for Optimization of ART: The (mo)BETTA Trial
Actual Study Start Date :
Jun 6, 2018
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. Frequency of Maintaining Undetectable HIV-1 RNA [48 weeks]

    Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks

  2. 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

  1. Lean mass [48 weeks]

    Change in lean mass (total, limb) as measured by Dual-energy X-ray absorptiometry (DXA)

  2. Fat Mass [48 weeks]

    Change in fat mass (total, trunk, limb) as measured by DXA

  3. Bone Mineral Density (BMD) [48 weeks]

    Change in BMD as measured by DXA

  4. Hepatic Fat Content [48 weeks]

    Change hepatic fat content as measured by FibroScan controlled attenuation parameter (CAP)

  5. Total cholesterol [48 weeks]

    Change in total cholesterol level

  6. HDL cholesterol [48 weeks]

    Change in HDL cholesterol level

  7. Triglycerides [48 weeks]

    Change in Triglyceride level

  8. LDL cholesterol [48 weeks]

    Change in LDL cholesterol

  9. Insulin level [48 weeks]

    Change in Insulin level

  10. Glucose level [48 weeks]

    Change in Glucose level

  11. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Jordan Elizabeth Lake, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03348163
Other Study ID Numbers:
  • HSC-MS-17-0480
First Posted:
Nov 20, 2017
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jordan Elizabeth Lake, Associate Professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022