COMPANY
ViiV Healthcare
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start Phase 1: A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV source ↗
- Trial start 2: A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) source ↗
- Trial start Phase 1: A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants source ↗
- Trial start Phase 3: A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment source ↗
- Trial start Phase 3: 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 source ↗
- Trial start Phase 1: Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184 source ↗
- Trial start Phase 1: A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants source ↗
- Trial start Phase 1/Phase 2: A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 source ↗
- Trial start 2: A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) source ↗
- Trial start Phase 1: A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV source ↗
- Trial start Phase 1: A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults source ↗
- Trial start Phase 1: A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV source ↗
- Trial start Phase 1: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults source ↗
- Trial start Phase 2: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M) source ↗
- Trial start Phase 1: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV source ↗
- Trial start Phase 3: A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 source ↗
- Trial start Phase 1: A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV source ↗
- Trial start 1: VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI) source ↗
- Trial start Phase 3: Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) source ↗
- Trial start Phase 1: A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants source ↗
- Trial start Phase 1: First Time in Human Study of Long Acting VH4524184 Formulations source ↗
- Trial start Phase 1: A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants source ↗
- Trial start Phase 3: A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency source ↗
- Trial start Phase 2: VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1 source ↗
- Trial start Phase 2: A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1 source ↗
Upcoming milestones
- Jan 22, 2027 (ESTIMATED) · Phase 1 · A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV · NCT07053384
- Mar 9, 2027 (ESTIMATED) · Phase 1 · A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults · NCT06786520
- May 5, 2027 (ESTIMATED) · Phase 1 · A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · NCT07525544
- Jun 8, 2027 (ESTIMATED) · Phase 1 · A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants · NCT05418868
- Jun 11, 2027 (ESTIMATED) · 2 · A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · NCT07202546
- Jan 21, 2028 (ESTIMATED) · Phase 1 · First Time in Human Study of Long Acting VH4524184 Formulations · NCT06310551
- Aug 16, 2028 (ESTIMATED) · Phase 1 · A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV · NCT06724640
- Jan 2, 2029 (ESTIMATED) · Phase 1 · A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants · NCT07818915
Clinical trials (lead sponsor) Showing 50 of 265
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06741397 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M) | Phase 2 | Active, not recruiting | Dec 20, 2024 | Sep 9, 2026 (actual) |
| NCT06694805 | A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 | Phase 3 | Active, not recruiting | Dec 2, 2024 | Aug 19, 2026 (actual) |
| NCT05514509 | A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories | Phase 4 | Completed | Oct 28, 2022 | Sep 2, 2025 (actual) |
| NCT07650916 | 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 | Phase 3 | Recruiting | Jun 25, 2026 | Sep 4, 2029 (estimated) |
| NCT07053384 | A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | Phase 1 | Active, not recruiting | Jul 10, 2025 | Jan 22, 2027 (estimated) |
| NCT07822477 | A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV | Phase 1 | Not yet recruiting | Nov 6, 2026 | May 9, 2029 (estimated) |
| NCT07818915 | A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants | Phase 1 | Not yet recruiting | Sep 15, 2026 | Jan 2, 2029 (estimated) |
| NCT07816250 | A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) | 2 | Not yet recruiting | Oct 19, 2026 | Jun 10, 2032 (estimated) |
| NCT02362503 | Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients | Phase 3 | Active, not recruiting | Feb 23, 2015 | Aug 18, 2016 (actual) |
| NCT07393659 | A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment | Phase 3 | Recruiting | Jul 21, 2026 | Sep 14, 2032 (estimated) |
| NCT06310551 | First Time in Human Study of Long Acting VH4524184 Formulations | Phase 1 | Recruiting | Mar 21, 2024 | Jan 21, 2028 (estimated) |
| NCT06012136 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults | Phase 1 | Completed | Aug 24, 2023 | Jun 9, 2026 (actual) |
| NCT02938520 | 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 | Oct 27, 2016 | Aug 30, 2018 (actual) |
| NCT06134362 | Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) | Phase 3 | Active, not recruiting | May 14, 2024 | Mar 14, 2029 (estimated) |
| NCT05996471 | A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) | Phase 2 | Active, not recruiting | Aug 17, 2023 | May 27, 2026 (actual) |
| NCT07202546 | A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2 | Recruiting | Feb 11, 2026 | Jun 11, 2027 (estimated) |
| NCT07525544 | A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | Phase 1 | Recruiting | May 14, 2026 | May 5, 2027 (estimated) |
| NCT05911360 | A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF | Phase 3 | Completed | Jul 7, 2023 | Jan 23, 2026 (actual) |
| NCT02951052 | 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 | Oct 28, 2016 | May 29, 2018 (actual) |
| NCT05979311 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy | Phase 3 | Active, not recruiting | Feb 21, 2024 | Apr 15, 2026 (actual) |
| NCT07636928 | Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184 | Phase 1 | Recruiting | Jun 4, 2026 | Aug 20, 2026 (estimated) |
| NCT06652958 | A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV | Phase 1 | Active, not recruiting | Oct 2, 2024 | Sep 9, 2026 (estimated) |
| NCT04484337 | Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants | Phase 1 | Completed | Jul 31, 2020 | May 5, 2023 (actual) |
| NCT05917509 | A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy | Phase 3 | Completed | Jul 6, 2023 | Sep 16, 2025 (actual) |
| NCT07275606 | A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 | Phase 1/Phase 2 | Recruiting | Apr 15, 2026 | Oct 10, 2029 (estimated) |
| NCT07066722 | A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults | Phase 1 | Completed | Jul 7, 2025 | Dec 17, 2025 (actual) |
| NCT06033547 | A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants | Phase 1 | Completed | Sep 12, 2023 | Jul 25, 2025 (actual) |
| NCT03016533 | Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019 | Phase 3 | Completed | Jun 6, 2017 | Dec 24, 2024 (actual) |
| NCT05631704 | A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity | Phase 1 | Completed | Dec 2, 2022 | Jul 27, 2023 (actual) |
| NCT05418868 | A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants | Phase 1 | Recruiting | Jun 14, 2022 | Jun 8, 2027 (estimated) |
| NCT05374525 | A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States | Phase 4 | Completed | May 18, 2022 | Aug 8, 2024 (actual) |
| NCT03682848 | Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents | Phase 3 | Completed | May 6, 2019 | Dec 1, 2021 (actual) |
| NCT06970223 | A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV | Phase 1 | Active, not recruiting | Apr 22, 2025 | Jul 15, 2025 (actual) |
| NCT06724640 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV | Phase 1 | Recruiting | Dec 16, 2024 | Aug 16, 2028 (estimated) |
| NCT06061081 | A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1 | Phase 2 | Terminated | Dec 21, 2023 | Aug 27, 2024 (actual) |
| NCT06039579 | Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults | Phase 2 | Completed | Oct 25, 2023 | Jun 24, 2024 (actual) |
| NCT03299049 | Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults | Phase 3 | Active, not recruiting | Oct 27, 2017 | Jun 6, 2019 (actual) |
| NCT03754803 | Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany | Not listed | Completed | Nov 8, 2018 | May 6, 2024 (actual) |
| NCT05163522 | First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants | Phase 1 | Completed | Dec 13, 2021 | Jun 21, 2023 (actual) |
| NCT04493684 | GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers | Phase 1 | Completed | Jul 31, 2020 | Aug 30, 2021 (actual) |
| NCT06214052 | VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1 | Phase 2 | Completed | Feb 7, 2024 | Jun 12, 2024 (actual) |
| NCT06786520 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | Phase 1 | Active, not recruiting | Jan 17, 2025 | Mar 9, 2027 (estimated) |
| NCT04233047 | Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) | Not listed | Available | Not listed | Not listed |
| NCT06533280 | VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI) | 1 | Withdrawn | Aug 2, 2024 | Aug 14, 2024 (actual) |
| NCT04982445 | Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.) | Phase 4 | Completed | Nov 18, 2021 | Jan 31, 2024 (actual) |
| NCT05393271 | First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants | Phase 1 | Completed | Oct 3, 2022 | Apr 24, 2023 (actual) |
| NCT06368986 | A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants | Phase 1 | Completed | Apr 17, 2024 | Oct 2, 2024 (actual) |
| NCT04019873 | 'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor | Not listed | Completed | Nov 18, 2019 | Apr 14, 2023 (actual) |
| NCT06310616 | A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants | Phase 1 | Completed | Mar 6, 2024 | Aug 15, 2024 (actual) |
| NCT05896748 | 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 | Nov 8, 2022 | Sep 14, 2023 (actual) |
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