(mo)BETTA Trial in Transwomen for Optimization of ART

NCT03348163 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HSC-MS-17-0480
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Keywords

Transgender women; Bictegravir

Outcome Measures

Primary Outcomes (2)

• Frequency of Maintaining Undetectable HIV-1 RNA

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

  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)

  48 weeks

Secondary Outcomes (76)

• Fat Mass, Total

  Baseline

• Fat Mass, Total

  48 weeks

• Fat Mass, Trunk

  Baseline

• Fat Mass, Trunk

  48 weeks

• Fat Mass, Limbs

  baseline

Study Arms (2)

Switch ART

EXPERIMENTAL

Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks

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.

Drug: Current ART

Interventions

B/FTC/TAF DRUG

B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)

Switch ART

Current ART DRUG

Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.

Continue Current ART

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified transgender women (TW)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Gilead Sciences: collaborator

Study Sites (1)

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Jordan Elizabeth Lake, MD, Associate Professor
• Organization: The University of Texas Health Science Center at Houston

Jordan.E.Lake@uth.tmc.edu

(713) 500-6759

Study Officials

• Jordan E Lake, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 20, 2017
• Study Start: June 6, 2018
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 3, 2022
• Results First Posted: October 3, 2022

Record last verified: 2022-09

Locations

US (1)