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CAB LA

DRUG12 trials

Sponsors

ViiV Healthcare, National Institute of Allergy and Infectious Diseases (NIAID), Janssen Research & Development, LLC

Conditions

HIV InfectionsHealthyInfection, Human Immunodeficiency Virus

Phase 1

A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
CompletedNCT03422172
ViiV HealthcareHIV Infections
Start: 2018-04-10End: 2020-04-20Updated: 2021-05-13
A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants
CompletedNCT05112939
Janssen Research & Development, LLCHealthy
Start: 2021-11-16End: 2024-05-23Updated: 2025-02-28
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
Active, not recruitingNCT06786520
ViiV HealthcareHIV Infections
Start: 2025-01-17End: 2027-11-08Updated: 2025-06-19

Phase 2

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
CompletedNCT02120352
ViiV HealthcareHIV Infections, Infection, Human Immunodeficiency Virus
Start: 2014-04-28End: 2023-04-20Updated: 2024-06-12
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
CompletedNCT02720094
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2016-12-19End: 2025-03-31Updated: 2026-03-19
Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
CompletedNCT03639311
ViiV HealthcareHIV Infections
Start: 2018-09-24End: 2023-01-30Updated: 2024-06-11
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males
CompletedNCT04692077
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2020-02-19End: 2023-07-07Updated: 2025-05-20
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females
CompletedNCT04824131
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2020-11-04End: 2023-01-10Updated: 2024-12-03
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)
Active, not recruitingNCT06741397
ViiV HealthcareHIV Infections
Start: 2024-12-20End: 2029-01-10Updated: 2025-11-18

Phase 3

Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
Active, not recruitingNCT03164564
National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections
Start: 2017-11-07End: 2026-10-17Updated: 2025-10-09
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
CompletedNCT04399551
ViiV HealthcareHIV Infections
Start: 2020-09-28End: 2023-03-13Updated: 2024-04-05
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)
RecruitingNCT06134362
ViiV HealthcareHIV Infections
Start: 2024-05-14End: 2029-01-01Target: 3508Updated: 2025-12-22

Related Papers

Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083.
2025-12-01
Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control.
2025-07-041 citations
Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)—a hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: study protocol
BMJ Open2025-04-012 citations
Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084-01): a single-arm, open-label, phase 2b trial.
2025-03-124 citations
Features of HIV Infection in the Context of Long-Acting Cabotegravir Preexposure Prophylaxis
UNC Libraries2025-01-25
Pharmacologic evaluation of delayed long-acting cabotegravir administration among cisgender women in HPTN 084
Antimicrobial Agents and Chemotherapy2024-09-272 citations
Implementation of long‐acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations
Journal of the International AIDS Society2024-07-017 citations
Long-acting cabotegravir pharmacokinetics with and without oral lead-in for HIV PrEP
Antimicrobial Agents and Chemotherapy2024-05-067 citations
Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial.
2023-11-0942 citations
Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial.
2023-09-296 citations
Cabotegravir and Rilpivirine Long-Acting Antiretroviral Therapy Administered Every 2 Months is Cost-Effective for the Treatment of HIV-1 in Spain.
2023-07-1410 citations
Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.
2022-04-01401 citations
Safety, Tolerability, Pharmacokinetics, and Acceptability of Oral and Long-Acting Cabotegravir in HIV-Negative Chinese Men.
2022-02-079 citations
Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy
AIDS2021-10-1334 citations
Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study
Open Forum Infectious Diseases2021-08-2555 citations
Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women
New England Journal of Medicine2021-08-11765 citations
Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M).
2021-05-3156 citations
Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials
JAIDS Journal of Acquired Immune Deficiency Syndromes2020-08-21135 citations
Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial
UNC Libraries2020-08-19
Evaluation of the effect of UGT1A1 polymorphisms on the pharmacokinetics of oral and long-acting injectable cabotegravir
Journal of Antimicrobial Chemotherapy2020-03-2711 citations

7 more papers not shown