Last updated: 06/17/2025 07:20:08

Post marketing surveillance to monitor the safety and effectiveness of Vocabria tablet, Vocabria injection, and Rekambys injection in Korean participants for the treatment of HIV-1 infection

GSK study ID
218027
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open label, multi-centre, post marketing surveillance to monitor the safety and effectiveness of Vocabria tablet, Vocabria injection, Rekambys injection administered in Korean subjects for treatment of HIV-1 infection in real world practice
Trial description: This study aims to assess the safety and effectiveness of Vocabria tablets, Vocabria injections, and Rekambys injections in Korean participants with HIV, as well as collect their treatment satisfaction with the injection options.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Present rate of adverse events (AEs) after the administration of Vocabria tablet

Timeframe: Up to 28 days after first administration of Vocabria tablet

Present rate of adverse drug reactions (ADRs) after the administration of Vocabria tablet

Timeframe: Up to 28 days after first administration of Vocabria tablet

Present rate of serious adverse events (SAEs) after the administration of Vocabria tablet

Timeframe: Up to 28 days after first administration of Vocabria tablet

Present rate of serious ADRs after the administration of Vocabria tablet

Timeframe: Up to 28 days after first administration of Vocabria tablet

Present rate of AEs after the administration of Vocabria injection and Rekambys injection

Timeframe: End of follow up of Vocabria injection and Rekambys injection

Present rate of ADRs after the administration of Vocabria injection and Rekambys injection

Timeframe: End of follow up of Vocabria injection and Rekambys injection

Present rate of SAEs after the administration of Vocabria injection and Rekambys injection

Timeframe: End of follow up of Vocabria injection and Rekambys injection

Present rate of serious ADRs after the administration of Vocabria injection and Rekambys injection

Timeframe: End of follow up of Vocabria injection and Rekambys injection

Secondary outcomes:

PGA(Physician’s Global Assessment) with reference to HIV-1 RNA count or/and injection treatment switching

Timeframe: At least 28 days after first administration of Vocabria tablet

PGA with reference to HIV-1 RNA count at 24 weeks (window period – 4 weeks) after first administration of Vocabria injection and Rekambys injection

Timeframe: At least 24 weeks after first administration of Vocabria injection and Rekambys injection

Human Immunodeficiency Virus Treatment Satisfaction Questionnaire- Status version (HIVSTQs) results for Vocabria injection and Rekambys injection

Timeframe: At Baseline (first administration of Vocabria injection and Rekambys injection)

HIVSTQs and Human Immunodeficiency Virus Treatment Satisfaction Questionnaire- Change version (HIVTSQc) results for Vocabria injection and Rekambys injection

Timeframe: 24 weeks after Vocabria injection and Rekambys injection administration

Interventions:
Not applicable
Enrollment:
600
Primary completion date:
2027-30-12
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
HIV infections
Product
cabotegravir
Collaborators
Janssen
Study date(s)
April 2025 to December 2027
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Vocabria tablet
  • Combination with rilpivirine tablet for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than [<] 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine
  • Vocabria tablet
  • Patients with previous hypersensitivity reaction to cabotegravir
Inclusion and exclusion criteria
Inclusion criteria:

    Vocabria tablet

    • Combination with rilpivirine tablet for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than [<] 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine
  • oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension, a component of cabotegravir and rilpivirine extended-release injectable suspensions.

    • oral therapy for patients who will miss planned injection dosing with cabotegravir and rilpivirine injection.

    • Patients who will administer Vocabria tablet in accordance with the product information approved in Korea. Vocabria injection
    • Combination with rilpivirine injection, for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the cabotegravir and rilpivirine.
    • Patients who will administer Vocabria injection in accordance with the product information approved in Korea. Rekambys injection
    • Combination with cabotegravir injection, for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the cabotegravir and rilpivirine.
    • Patients who will administer Rekambys injection in accordance with the product information approved in Korea.
Exclusion criteria:

    Vocabria tablet

    • Patients with previous hypersensitivity reaction to cabotegravir
    • Patients concomitant use with Rifampin, rifapentine, carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
    • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption. Vocabria injection
    • Patients with hypersensitivity to the active substance or to any of the excipients
    • Patients concomitant use with rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin, or phenobarbital. Rekambys injection
    • Patients with Hypersensitivity to the active substance or to any of the excipients
    • Patients concomitant use of the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction), which may result in the loss of therapeutic effect of REKAMBYS
  • the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
  • the antimycobacterial rifabutin, rifampicin, rifapentine
  • the systemic glucocorticoid dexamethasone, except as a single dose treatment

    • St John’s wort (Hypericum perforatum).

    • Patients use proton pump inhibitors when using oral rilpivirine.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Daegu, South Korea, 700-721
Status
Recruiting
Contact us

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Additional information
Not applicable
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