Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)

NCT04240210 | Terminated Phase 4 FDA Drug

• 1 other identifier: TMC114FD2HTX4005
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may better tolerate Symtuza and subsequently have improved adherence.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Part 1 of the study is a cohort survey of change in adherence, tolerability and safety of subjects who report poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens.

  To evaluate trends and patterns in subjects who report sub-optimal adherence, analyzed by intention to treat with Integrase Inhibitor based Antiretroviral containing regimens, based upon the subjects completion of the Midland ART Adherence Survey (MAAS)

  4 months

Secondary Outcomes (4)

• To determine potential changes in ART adherence in subjects who report sub-optimal adherence due to side effects from integrase containing regimens after switching to Symtuza.

  4 months

• To evaluate the tolerability of switching from an integrase inhibitor containing regimen to Symtuza.

  4 months

• Safety and efficacy of switching from integrase inhibitor containing regimen to Symtuza as determined by the proportion of subjects with virologic failure, a change in laboratory parameters and change in CD4 cell count from baseline.

  4 months

• To evaluate for potential weight loss when switching from integrase inhibitor containing regimen to Symtuza.

  4 months

Study Arms (2)

To assess degree of adherence to ART in a real world seeting.

NO INTERVENTION

Part I of the study is a Cohort Survey of HIV+ outpatient clinic patients currently receiving ART to assess medication adherence and tolerability by determining a change in adherence and tolerability from baseline to 4 months, measured by standardized patient reported outcome and adherence surveys

Potential changes in ART adherence when switced to Symtuza.

EXPERIMENTAL

Part 2 of the study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months.

Drug: Symtuza

Interventions

Symtuza DRUG

The study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months.

Potential changes in ART adherence when switced to Symtuza.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• HIV positive receiving ART of any type.
• Currently on an integrase containing regimen AND Reports non-adherent due to medication intolerance.
• GFR≥30mL/min.
• AST/ALT ≤ 3 times upper limit of normal. (AST- U/L 10-40), (ALT- U/L 9-46)
• Total bilirubin of ≤1.5 mg/dL.

You may not qualify if:

• Known resistance to darunavir or tenofovir
• Known intolerance to Symtuza or its components
• Current pregnancy
• Requires continued use of any of the agents in table 6.2.3.2.4
• Cirrhosis, regardless of compensation status
• Active, serious infections within 30 days of baseline
• History of malignancy within 5 years of baseline, except cutaneous Kaposi's sarcoma, basal cell or resected non-invasive cutaneous squamous cell carcinoma
• Life expectancy of less than a year
• Participation in any other investigation study 30 days prior to enrollment

Sponsors & Collaborators

• Midland Research Group, Inc.: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Midland Research Group, Inc

Oakland Park, Florida, 33334, United States

Location

Related Publications (3)

• Ortego C, Huedo-Medina TB, Llorca J, Sevilla L, Santos P, Rodriguez E, Warren MR, Vejo J. Adherence to highly active antiretroviral therapy (HAART): a meta-analysis. AIDS Behav. 2011 Oct;15(7):1381-96. doi: 10.1007/s10461-011-9942-x.

  PMID: 21468660 BACKGROUND

• Robbins RN, Spector AY, Mellins CA, Remien RH. Optimizing ART adherence: update for HIV treatment and prevention. Curr HIV/AIDS Rep. 2014 Dec;11(4):423-33. doi: 10.1007/s11904-014-0229-5.

  PMID: 25304006 BACKGROUND

• Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.

  PMID: 28993180 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

symtuza

Condition Hierarchy (Ancestors)

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

Study Officials

• Anthony Ciesielski, MD

  Midland Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 27, 2020
• Study Start: September 17, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)