VIIV HEALTHCARE PTY LTD

🇦🇺Australia

Country: 🇦🇺Australia

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Clinical Trials

Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

Phase 3

Active, not recruiting

Conditions: HIV Infections
Infection, Human Immunodeficiency Virus

Interventions: Drug: Cabotegravir (CAB) tablet
Drug: 2 NRTIs plus an INI, NNRTI, or PI
Drug: Rilpivirine (RPV) tablet
Drug: Cabotegravir - Injectable Suspension (CAB LA)
Drug: Rilpivirine - Injectable Suspension (RPV LA)

First Posted Date: 2016-11-01

Last Posted Date: 2024-02-14

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 618

Registration Number: NCT02951052

Locations: 🇸🇪
GSK Investigational Site, Stockholm, Sweden

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Phase 3

Active, not recruiting

Conditions: HIV Infections

Interventions: Drug: ABC/DTG/3TC STR - Tablet
Drug: Cabotegravir (CAB) tablet
Drug: Rilpivirine (RPV) tablet
Drug: DTG Tablet
Drug: Cabotegravir - Injectable Suspension (CAB LA)
Drug: Rilpivirine - Injectable Suspension (RPV LA)

First Posted Date: 2016-10-19

Last Posted Date: 2024-02-15

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 631

Registration Number: NCT02938520

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

Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: DTG/ABC/3TC FDC DISPERSIBLE TABLET
Drug: EPZICOM (ABC/3TC)
Drug: TIVICAY (DTG)

First Posted Date: 2016-09-08

Last Posted Date: 2017-08-04

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 20

Registration Number: NCT02893488

Locations: 🇺🇸
GSK Investigational Site, Overland Park, Kansas, United States

A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: BMS-663068 (1 tablet at 600 mg)
Drug: BMS-663068 (4 tablets at 150 mg each tablet)

First Posted Date: 2016-08-09

Last Posted Date: 2017-05-15

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 14

Registration Number: NCT02859259

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

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)

Phase 3

Completed

Conditions: Infection, Human Immunodeficiency Virus
HIV Infections

Interventions: Drug: Dolutegravir (DTG)
Drug: Lamivudine (3TC)
Drug: Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)

First Posted Date: 2016-07-13

Last Posted Date: 2023-12-07

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 722

Registration Number: NCT02831764

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

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)

Phase 3

Completed

Conditions: Infection, Human Immunodeficiency Virus
HIV Infections

Interventions: Drug: Dolutegravir (DTG)
Drug: Lamivudine (3TC)
Drug: Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)

First Posted Date: 2016-07-13

Last Posted Date: 2023-08-24

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 719

Registration Number: NCT02831673

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

Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: BMS-663068
Drug: BMS-626529

First Posted Date: 2016-06-20

Last Posted Date: 2017-07-21

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 36

Registration Number: NCT02805556

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

A Study to Evaluate the Effect of High Fat Meal on Cabotegravir

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: Cabotegravir 30 mg

First Posted Date: 2016-06-14

Last Posted Date: 2017-01-13

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 24

Registration Number: NCT02799264

Locations: 🇺🇸
GSK Investigational Site, Overland Park, Kansas, United States

Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus
HIV Infections

Interventions: Drug: DTG
Drug: RPV
Drug: DTG/RPV FDC

First Posted Date: 2016-04-18

Last Posted Date: 2019-07-15

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 118

Registration Number: NCT02741557

Locations: 🇺🇸
GSK Investigational Site, Overland Park, Kansas, United States

Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: Dolutegravir 50 mg tablet
Drug: Lamivudine 300 mg tablet
Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)
Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)

First Posted Date: 2016-04-14

Last Posted Date: 2017-01-18

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 30

Registration Number: NCT02738931

Locations: 🇺🇸
GSK Investigational Site, Overland Park, Kansas, United States

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