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)

Name: Clinical Trial NCT06134362
Creator: ViiV Healthcare
Keywords: HIV Infections, CAB LA, Phase 3, drug, clinical trial

A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

ViiV Healthcare·Phase 3·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: HIV Infections
Drug/Device/Intervention: CAB LA
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: ViiV Healthcare

Timeline & enrollment

Phase: Phase 3
Start date: Jan 05, 2024
End date: Mar 31, 2027
Enrollment: 3500 participants

Primary outcome

Number of participants with new HIV infection,Number of participants with new HIV infection by characteristic

Summary

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.

ICD-10 classifications

HIV disease resulting in other viral infectionsHIV disease resulting in other bacterial infectionsHIV disease resulting in multiple infectionsAcute HIV infection syndromeHIV disease resulting in other infectious and parasitic diseases

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06134362
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06134362 through Pure Global AI's free database. This Phase 3 trial is sponsored by ViiV Healthcare and is currently Not yet recruiting. The study focuses on HIV Infections. Target enrollment is 3500 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.