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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) - Trial NCT06134362

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.

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NCT06134362
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06134362
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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)
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

Study Focus

HIV Infections

CAB LA

Interventional

drug

Sponsor & Location

ViiV Healthcare

Timeline & Enrollment

Phase 3

Jan 05, 2024

Mar 31, 2027

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 infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06134362

Non-Device Trial