RecruitingPhase 3NCT06134362

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


Sponsor

ViiV Healthcare

Enrollment

3,508 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This trial provides long-acting injectable cabotegravir (CAB LA) for HIV prevention (PrEP) to people who previously participated in related studies and are still at risk for HIV. You may be eligible if... - You recently completed or are currently enrolled in the HPTN 083 or HPTN 084 open-label extension study on the cabotegravir arm - You are HIV-negative and still considered at risk - All your HIV tests at screening are nonreactive You may NOT be eligible if... - You withdrew early from a prior cabotegravir PrEP study - You have a reactive (positive) HIV test result at screening - You completed the prior study more than 3 months ago without prior approval Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCAB LA

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


Locations(34)

GSK Investigational Site

Almagro, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Francistown, Botswana

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Rio de Janeiro, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Mbabane, Eswatini

GSK Investigational Site

Kisumu, Kenya

GSK Investigational Site

Blantyre, Malawi

GSK Investigational Site

Lilongwe, Malawi

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Lima, Peru

GSK Investigational Site

Piura, Peru

GSK Investigational Site

Cape Town, South Africa

GSK Investigational Site

City of Cape Town, South Africa

GSK Investigational Site

City of Cape Town, South Africa

GSK Investigational Site

City of Johannesburg, South Africa

GSK Investigational Site

Durban, South Africa

GSK Investigational Site

Durban, South Africa

GSK Investigational Site

Isipingo, South Africa

GSK Investigational Site

Sol Plaatjie, South Africa

GSK Investigational Site

Chiang Mai, Chiang Mai, Thailand

GSK Investigational Site

Pathum Wan, Thailand

GSK Investigational Site

Entebbe, Uganda

GSK Investigational Site

Kampala, Uganda

GSK Investigational Site

Kampala, Uganda

GSK Investigational Site

Chitungwiza, Zimbabwe

GSK Investigational Site

Chitungwiza, Zimbabwe

GSK Investigational Site

Chitungwiza, Zimbabwe

GSK Investigational Site

Harare, Zimbabwe

GSK Investigational Site

Harare, Zimbabwe

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NCT06134362


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