A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

August 13, 2026 updated by: ViiV Healthcare

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

564

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sebastian Nunez
        • Contact:
        • Contact:
      • Buenos Aires, Argentina, C1023AAB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Veronica Lacal Ridilenir
      • Buenos Aires, Argentina, 1427
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Cahn
      • Ciudad Autonoma Buenos Aires, Argentina, C1405CKC
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ezequiel Cordova
      • Ciudad Autonoma Buenos Aires, Argentina, C1425AWK
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Lopardo
      • Córdoba, Argentina, X5000JJS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo Martins
      • Rosario, Argentina, 2000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Lupo
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Gonzalo Tomas
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark O'Reilly
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Bloch
    • Queensland
      • Taringa, Queensland, Australia, 4068
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fiona Bisshop
        • Contact:
        • Contact:
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2T1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Malcolm Hedgcock
    • Ontario
      • Toronto, Ontario, Canada, M5G 1K2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mona Loutfy
    • Quebec
      • Montreal, Quebec, Canada, H2L 4E9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elise Sasseville
      • Montreal, Quebec, Canada, H2L 4P9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Szabo
  • Japan
      • Aichi, Japan, 460-0001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshiyuki Yokomaku
      • Kanagawa, Japan, 221-0855
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yukihiro Yoshimura
      • Osaka, Japan, 540-0006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dai Watanabe
      • Tokyo, Japan, 162-8655
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Gatanaga
      • Tokyo, Japan, 108-8639
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eisuke Adachi
      • Tokyo, Japan, 113-8677
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryoko Sekiya
  • Mexico
      • Guadajalara, Mexico, 44280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luz Alicia Gonzalez-Hernandez
      • Mexico City, Mexico, 06760
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edgar Perez-Barragan
      • Mexico City, Mexico, 14080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alvaro Lopez Iñiguez
      • Mérida, Mexico, 97070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Orlando Paredes Ceballos
    • Nuevo León
      • San Pedro Garza García, Nuevo León, Mexico, 66260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reynaldo Lara-Medrano
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Morales-Ramirez
  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Reus Bañuls
      • Badalona, Spain, 08005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Bonjoch Badia
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joaquin Burgos Cibrian
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josep Mallolas Masferrer
      • Barcelona, Spain, 08026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula Prieto
      • Barcelona, Spain, 8907
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arkaitz Imaz Vacas
      • Burgos, Spain, 09006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Buzon
      • Cartagena Murcia, Spain, 30202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Jesús Vera Méndez
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ignacio Pérez Valero
        • Contact:
        • Contact:
      • Elche Alicante, Spain, 03203
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • MAR MASIA
        • Contact:
        • Contact:
      • Madrid, Spain, 28031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermo Cuevas Tascon
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Luisa Montes Ramirez
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Serrano Villar
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vicente Estrada
        • Contact:
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafael Rubio
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Diez Romero
      • Madrid, Spain, 28224
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto Díaz de Santiago
      • Sabadell Barcelona, Spain, 08208
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Navarro Vilasaró
      • Seville, Spain, Sevilla
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Macias
      • Valencia, Spain, 46014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel García Deltoro
      • Vigo Pontevedra, Spain, 36312
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Ocampo Hermidia
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steve Taylor
      • London, United Kingdom, W2 1NY
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Caroline Foster
      • London, United Kingdom, WC1E 6JB
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah Pett
      • London, United Kingdom, SW10 9NH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruth Byrne
      • London, United Kingdom, E1 1FR
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chloe Orkin
        • Contact:
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Douglas Cunningham
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franco Felizarta
      • Los Angeles, California, United States, 90027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Towner
      • Los Angeles, California, United States, 90036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Ruane
      • San Diego, California, United States, 92103
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Wilkin
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Onyema Ogbuagu
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20017
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Theo Hodge
    • Florida
      • DeLand, Florida, United States, 32720
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Godson Oguchi
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Sension
      • Ft. Pierce, Florida, United States, 34982
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Moti Ramgopal
      • Miami, Florida, United States, 33136
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Mitchell
      • Orlando, Florida, United States, 32803
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charlotte-Paige Rolle
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mitchell Whitehead
        • Contact:
        • Contact:
      • Vero Beach, Florida, United States, 32960
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gerald Pierone
      • West Palm Beach, Florida, United States, 33409
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Bolivar
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olayemi Osiyemi
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra Dretler
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leonard Johnson
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Blair Thedinger
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jerry Cade
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jihad Slim
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joel Gallant
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sharon Nachman
        • Contact:
        • Contact:
      • Syracuse, New York, United States, 13057
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elizabeth Asiago-Reddy
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cornelius Van Dam
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Bazan
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • William Short
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cynthia Brinson
      • Dallas, Texas, United States, 75246
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Bettacchi
      • Dallas, Texas, United States, 75219
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marc Tribble
      • El Paso, Texas, United States, 79902
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ogechika Alozie
      • Houston, Texas, United States, 77098
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gordon Crofoot, Jr., MD
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Harry Rosado-Santos
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Saabiye
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Peter Shalit
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Patient Study Participant (PSP) Inclusion criteria:

  • Adults and adolescents with HIV-1 infection aged 12 years or older with a weight >35 kg.
  • Documented HIV-1 RNA measurements <50 copies/mL in the 12 months prior to Screening.
  • HIV-1 RNA <50 copies/mL at screening assessment.
  • Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
  • Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).

Exclusion criteria:

Patient Study Participant (PSP) Exclusion criteria:

  • Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
  • Any history of receiving long-acting therapy for HIV.
  • Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection.
  • Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAB ULA+ RPV ULA
Participants will receive CAB ULA+RPV ULA.
Drug: CAB ULA
CAB ULA will be administered.
Drug: RPV ULA
RPV ULA will be administered.
Active Comparator: CAB LA+ RPV LA
Participants will receive CAB LA+RPV LA.
Drug: CAB LA
CAB LA will be administered.
Drug: RPV LA
RPV LA will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm
Time Frame: At Month 11
At Month 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm
Time Frame: At Month 23
At Month 23
Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm
Time Frame: At Month 11 and Month 23
At Month 11 and Month 23
Percentage of participants with confirmed virologic failure (CVF)
Time Frame: Up to Month 23
CVF is defined as 2 consecutive HIV-1 RNA levels >=200 c/mL.
Up to Month 23
Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5
Time Frame: Up to Month 23
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Up to Month 23
Number of participants with drug-related serious adverse events (SAEs)
Time Frame: Up to Month 23
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Up to Month 23
Number of participants who discontinue treatment due to AEs or injection intolerability
Time Frame: Up to Month 23
Up to Month 23
Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV
Time Frame: Up to Month 23
Up to Month 23
Ctrough of CAB and RPV
Time Frame: Up to Month 23
Up to Month 23
Maximum concentrations post dose (Cmax) of CAB and RPV
Time Frame: Up to Month 23
Up to Month 23
Area under the curve (AUC) of CAB and RPV
Time Frame: Up to Month 23
Up to Month 23
Absolute value of CD4+ cell counts in participants
Time Frame: Up to Month 23
Up to Month 23
Change from Baseline in CD4+ cell counts in participants
Time Frame: At Month 23 compared to baseline (Day 1)
At Month 23 compared to baseline (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2026

Primary Completion (Estimated)

September 4, 2029

Study Completion (Estimated)

September 4, 2029

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222794
  • 2024-518511-19-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer tohttps://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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