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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)

NCT06134362 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3508

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

CAB LA

Participants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W).

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2029-01-01
Completion
2029-01-01
FDA Drug
Yes

Countries

  • Argentina
  • Botswana
  • Brazil
  • Eswatini
  • Kenya
  • Malawi
  • Peru
  • South Africa
  • Thailand
  • Uganda
  • Zimbabwe

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06134362 on ClinicalTrials.gov