VIIV HEALTHCARE PTY LTD

🇦🇺Australia

Country: 🇦🇺Australia

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Clinical Trials

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

Phase 3

Completed

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1)

Interventions: Drug: Cabotegravir - Injectable Suspension (CAB LA)
Drug: Rilpivirine - Injectable Suspension (RPV LA)

First Posted Date: 2023-06-09

Last Posted Date: 2024-11-26

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 94

Registration Number: NCT05896748

Locations: 🇬🇧
GSK Investigational Site, London, United Kingdom

A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Cabotegravir IR Formulation (reference)
Drug: Cabotegravir DT Formulation (test 1)
Drug: Cabotegravir DT Formulation (test 2)

First Posted Date: 2023-03-20

Last Posted Date: 2023-12-13

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 24

Registration Number: NCT05776108

Locations: 🇺🇸
GSK Investigational Site, Austin, Texas, United States

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Phase 1

Recruiting

Conditions: HIV Infections

Interventions: Drug: Dolutegravir/Rilpivirine FDC

First Posted Date: 2023-01-06

Last Posted Date: 2024-07-12

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 20

Registration Number: NCT05674656

Locations: 🇺🇸
GSK Investigational Site, Houston, Texas, United States

A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity

Phase 1

Recruiting

Conditions: HIV Infections

Interventions: Drug: VH4524184
Drug: Placebo
Drug: Midazolam

First Posted Date: 2022-11-30

Last Posted Date: 2023-01-13

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 105

Registration Number: NCT05631704

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Phase 4

Recruiting

Conditions: HIV Infections

Interventions: Drug: APRETUDE
Drug: Cabotegravir tablet

First Posted Date: 2022-08-24

Last Posted Date: 2024-05-31

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 250

Registration Number: NCT05514509

Locations: 🇺🇸
GSK Investigational Site, Norfolk, Virginia, United States

A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Phase 1

Recruiting

Conditions: HIV Infections

Interventions: Drug: RPV
Drug: Cabotegravir 200 mg/mL
Drug: Cabotegravir >=400 mg/mL
Drug: rHuPH20
Drug: Cabotegravir Formulation I

First Posted Date: 2022-06-14

Last Posted Date: 2024-10-17

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 180

Registration Number: NCT05418868

Locations: 🇺🇸
GSK Investigational Site, Austin, Texas, United States

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: VH4011499
Drug: Placebo
Drug: Midazolam

First Posted Date: 2022-05-26

Last Posted Date: 2023-07-06

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 73

Registration Number: NCT05393271

Locations: 🇺🇸
GSK Investigational Site, Austin, Texas, United States

A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Phase 4

Active, not recruiting

Conditions: HIV Infections

Interventions: Drug: APRETUDE
Drug: Cabotegravir OLI

First Posted Date: 2022-05-16

Last Posted Date: 2024-02-14

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 116

Registration Number: NCT05374525

Locations: 🇺🇸
GSK Investigational Site, Seattle, Washington, United States

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Phase 1

Completed

Conditions: HIV Infections

Interventions: Biological: VH3810109
Biological: rHuPH20

First Posted Date: 2022-03-22

Last Posted Date: 2023-05-11

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 24

Registration Number: NCT05291520

Locations: 🇺🇸
GSK Investigational Site, Austin, Texas, United States

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: VH4004280
Drug: Placebo
Drug: Midazolam

First Posted Date: 2021-12-20

Last Posted Date: 2023-08-30

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 73

Registration Number: NCT05163522

Locations: 🇺🇸
GSK Investigational Site, Las Vegas, Nevada, United States

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