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Last Updated: December 24, 2024

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CLINICAL TRIALS PROFILE FOR APRETUDE


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All Clinical Trials for APRETUDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT05374525 ↗ A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States Not yet recruiting ViiV Healthcare Phase 4 2022-05-16 This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments.
NCT05514509 ↗ A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories Not yet recruiting ViiV Healthcare Phase 4 2022-08-23 The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
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) Not yet recruiting GlaxoSmithKline Phase 3 2024-04-01 The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
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) Not yet recruiting PPD Phase 3 2024-04-01 The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
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) Not yet recruiting ViiV Healthcare Phase 3 2024-04-01 The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.
NCT06138600 ↗ Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa Active, not recruiting Bill and Melinda Gates Foundation Phase 3 2023-11-01 This is a mixed methods study employing a convergence model triangulation design. Participants in the study will be sexually active young adults starting PrEP at private pharmacies, who will be offered either CAB-LA, oral PrEP (TDF/FTC[3TC]), or PrEP deferment at each of their regular visits, with the option to switch between options for up to 15 months, with a final exit interview following the transition to standard-of-care. The number of study visits will vary, depending on participant PrEP choices. Those choosing oral PrEP, will be seen 3 monthly from V2 onwards, but those choosing CAB-LA, will be seen 2 monthly from V2. A maximum of 9 visits is possible.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for APRETUDE

Condition Name

Condition Name for APRETUDE
Intervention Trials
HIV Infections 4
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Condition MeSH

Condition MeSH for APRETUDE
Intervention Trials
HIV Infections 4
Acquired Immunodeficiency Syndrome 1
Infections 1
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Clinical Trial Locations for APRETUDE

Trials by Country

Trials by Country for APRETUDE
Location Trials
South Africa 6
Brazil 3
Argentina 2
Peru 2
Thailand 2
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Clinical Trial Progress for APRETUDE

Clinical Trial Phase

Clinical Trial Phase for APRETUDE
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for APRETUDE
Clinical Trial Phase Trials
Not yet recruiting 3
Active, not recruiting 1
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Clinical Trial Sponsors for APRETUDE

Sponsor Name

Sponsor Name for APRETUDE
Sponsor Trials
ViiV Healthcare 4
GlaxoSmithKline 1
PPD 1
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Sponsor Type

Sponsor Type for APRETUDE
Sponsor Trials
Industry 6
Other 2
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