NCT03348163 ((mo)BETTA) is a Phase 4 clinical trial of B/FTC/TAF in HIV Infections, sponsored by The University of Texas Health Science Center, Houston.

Who is sponsoring NCT03348163?

NCT03348163 is sponsored by The University of Texas Health Science Center, Houston.

What drugs are being tested in NCT03348163?

Interventions in NCT03348163: B/FTC/TAF, Current ART.

What condition does NCT03348163 study?

NCT03348163 studies HIV Infections.

Is NCT03348163 still recruiting?

NCT03348163 is currently terminated. Last updated 3 October 2022.

Are results published for NCT03348163?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-10-03 · How we verify

NCT03348163: (mo)BETTA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

(mo)BETTA Trial in Transwomen for Optimization of ART

Terminated Phase 4 Results posted Last updated 3 October 2022

What this trial tests

Phase 4 trial testing B/FTC/TAF in HIV Infections in 26 participants. Terminated before completion.

Timeline

6 June 2018

Primary endpoint
15 December 2020

15 December 2020

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	6 June 2018
Primary completion	15 December 2020
Estimated completion	15 December 2020
Sites	1 location across United States

Drugs / interventions tested

B/FTC/TAF — full drug profile →
Current ART — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Maintaining Undetectable HIV-1 RNA Primary · 48 weeks

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

Group	Value	95% CI
Switch ART	10
Continue Current ART	8

Frequency of Adverse Events Primary · 48 weeks

Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes \>/= Grade 3 lab or clinical events)

Group	Value	95% CI
Switch ART	0
Continue Current ART	0

Fat Mass, Total Secondary · Baseline

Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	53.49	49.16 – 59.08
Continue Current ART	55.41	52.83 – 72.79

Fat Mass, Total Secondary · 48 weeks

Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	62.07	53.12 – 71.29
Continue Current ART	71.57	47.22 – 77.42

Fat Mass, Trunk Secondary · Baseline

Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	30.80	27.82 – 38.14
Continue Current ART	42.21	22.34 – 46.90

Fat Mass, Trunk Secondary · 48 weeks

Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	34.77	31.40 – 44.02
Continue Current ART	44.81	28.99 – 53.84

Fat Mass, Limbs Secondary · baseline

Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	21.09	16.19 – 23.50
Continue Current ART	19.60	12.30 – 20.77

Fat Mass, Limbs Secondary · 48 weeks

Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	23.59	17.92 – 25.48
Continue Current ART	22.50	16.33 – 35.39

Percentage of Fat Mass (Total) Secondary · Baseline

Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	33.70	31.47 – 36.80
Continue Current ART	32.00	30.80 – 38.20

Percentage of Fat Mass (Total) Secondary · 48 weeks

Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	35.70	33.00 – 40.00
Continue Current ART	34.00	29.60 – 44.10

Percentage of Fat Mass (Trunk) Secondary · Baseline

Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	40.15	34.20 – 42.25
Continue Current ART	38.20	30.35 – 41.70

Percentage of Fat Mass (Trunk) Secondary · 48 weeks

Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)

Group	Value	95% CI
Switch ART	41.90	37.70 – 44.15
Continue Current ART	43.30	31.20 – 45.90

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Optimizing HIV prevention and care for transgender adults.
Lake JE, Clark JL. · · 2019 · cited 9× · PMID 30703068 · DOI 10.1097/qad.0000000000002095
A Randomized Clinical Trial of Transgender Women Switching to B/F/TAF: The (mo)BETTA Trial.
Lake JE, Hyatt AN, Feng H, Debroy P, et al · · 2023 · cited 6× · PMID 37096146 · DOI 10.1093/ofid/ofad178

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente · Phase 4 · not yet recruiting
NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03348163 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
Last refreshed: 3 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03348163.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing