HIV InfectionsPhase 3PALISADENCT06134362
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 3 study testing CAB LA in people with HIV Infections, run by ViiV Healthcare at 33 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- CAB LA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,998 participants
- Where
- 33 sitesin 12 countries
- Study dates
- 14 May 2024to 14 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Type of participant
- Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:
- HPTN 083 open label extension
- HPTN 084 open label extension (including pregnancy sub-study)
- Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment.
- Participants who have prematurely withdrawn from prior CAB PrEP studies cannot enroll into this study.
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- Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
- Participants must have nonreactive HIV tests at Screening (rapid test, immunoassay [antigen/antibody] test and HIV-1 RNA results must all be available and nonreactive) and Day 1 (at least one of rapid test and immunoassay [antigen/antibody test] results must be available and nonreactive). Participants who have one or more reactive or positive HIV test result(s) will not be enrolled, even if subsequent confirmatory testing indicates they are not HIV-infected.
- Sex
- Males and Females:
- All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs.
- Females:
- Cisgender female participants who are of childbearing potential and who are engaging in sexual activity that could lead to pregnancy, must talk to the investigator about recommended contraception options. Contraception will be optional in this study. Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
- Pregnant participants from the HPTN 084 study are eligible to enroll into this study if they meet all eligibility criteria.
- Informed consent
- Participant or caregiver/legal guardian is able and willing to provide signed informed consent as described in Protocol Section 11.1.5, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Where applicable, participants must provide written assent.
Who cannot join
- Concurrent conditions/medical history (includes liver function)
- Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor.
- Previous premature discontinuation from IP in the parent study/sub-study.
- ALT >5 × ULN; or ALT>3 × ULN and bilirubin >1.5 × ULN (with >35% direct bilirubin) in the screening liver chemistry test result.
- Participants with known active hepatitis B infection (as indicated by a positive HBsAg and/or quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).
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- Known history of cirrhosis with or without viral hepatitis co-infection.
- Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) with a compound or device that is not commercially available within 30 days prior to signing informed consent, unless permission from the Medical Monitor is granted.
- Presence of or any history of allergy/sensitivity to the study drug or its components.
- Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator. Mild skin conditions may not be exclusionary at the discretion of the investigator or designee.
- Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs.
- Coagulopathy (primary or iatrogenic) which would contraindicate IM injection. Concomitant medications
- Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication.
- Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug: drug interactions with study treatment throughout the entire study period.
- Relevant habits
- Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- Any condition (i(including but not limited to substance use disorder) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
- Other
- Participant has in the last 14 days prior to screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical suspicion of HIV is ruled out with non-reactive results using appropriate HIV tests as per Inclusion Criterion #3.
- Participant is a ward of the state (e.g. child in care).
Trial locations and contacts
33 sites in 12 countries.
33 sites in 12 countries
South Africa8 sites
GSK Investigational Site
Cape Town, 7505
GSK Investigational Site
City of Cape Town, 755
GSK Investigational Site
City of Cape Town, 792
GSK Investigational Site
City of Johannesburg, 2001
GSK Investigational Site
Durban, 4110
GSK Investigational Site
Durban, 4400
GSK Investigational Site
Isipingo, 4110
GSK Investigational Site
Sol Plaatjie, 8301
Peru5 sites
GSK Investigational Site
Lima, 15001
GSK Investigational Site
Lima, 15024
GSK Investigational Site
Lima, 15088
GSK Investigational Site
Lima, Lima 04
GSK Investigational Site
Piura, 20000
Brazil4 sites
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 91350-200
GSK Investigational Site
Rio de Janeiro, 21040-360
GSK Investigational Site
São Paulo, 04121-000
GSK Investigational Site
São Paulo, 05403-000
Zimbabwe4 sites
GSK Investigational Site
Chitungwiza, 00263
GSK Investigational Site
Chitungwiza, 230221
GSK Investigational Site
Chitungwiza, 263
GSK Investigational Site
Harare
Argentina2 sites
GSK Investigational Site
Almagro, C1427CEA
GSK Investigational Site
Buenos Aires, 1221
Malawi2 sites
GSK Investigational Site
Blantyre
GSK Investigational Site
Lilongwe, CLW
Thailand2 sites
GSK Investigational Site
Chiang Mai, Chiang Mai, 50200
GSK Investigational Site
Pathum Wan, 10330
Uganda2 sites
GSK Investigational Site
Entebbe, 49
GSK Investigational Site
Kampala
About this study
Official title: 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
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
- Being tested
- CAB LA
- Keywords
- HIV, Human Immunodeficiency Virus, CAB LA, Cabotegravir, Apretude, PrEP, HPTN 083, HPTN 084, DAIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAB LADrug
Also called Apretude, CAB LA for PrEP
Participants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W).
| Study group | Role | What they receive |
|---|---|---|
| CAB LA 600 mg (Q8W) | Experimental | All enrolled participants have previously received CAB LA as part of the HPTN 083 and HPTN 084 parent studies or their sub-studies. Participants will continue receiving CAB LA 600 mg via gluteal intramuscular (IM) injection. Receives: Drug: CAB LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with new HIV infection
Measured: From Day 1 up to end of study (up to approximately [approx.] 3 years)
Number of participants with new HIV infection by characteristic
Relevant characteristics of new HIV infections will be assessed, including presence of viral resistance to CAB.
Measured: From Day 1 up to end of study (up to approx. 3 years)
Secondary outcomes (3)
Number of participants with serious adverse events (SAE) by severity
The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Measured: From Day 1 up to end of study (up to approx. 3 years)
Number of participants with Grade 3 and Grade 4 injection site reactions (ISRs)
ISRs may occur following intramuscular administration of CAB LA. Grade 3 refers to severe symptoms causing inability to perform usual social \& functional activities with intervention or hospitalization indicated. Grade 4 refers to potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability or death.
Measured: From Day 1 up to end of study (up to approx. 3 years)
Number of participants with any clinical or laboratory AE leading to discontinuation of CAB LA, by severity
Any clinical or laboratory AE that leads the participant to permanently discontinue CAB LA will be assessed. The severity scale is assessed as following: Grade 1 = mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated. Grade 2 = moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated. Grade 3 = severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated. Grade 4 = potentially life-threatening symptoms causing inability to perform self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death.
Measured: From Day 1 up to end of study (up to approx. 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start14 May 2024
- Primary completion14 Mar 2029 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,998 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134362
- Sponsor's protocol ID
- 221163
- Acronym
- PALISADE
- Status last verified
- Nov 2026
- First submitted
- 10 Nov 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06134362
- Acronym / sponsor ID
- PALISADE / 221163
- Conditions
- HIV Infections
- Keywords
- HIV, Human Immunodeficiency Virus, CAB LA, Cabotegravir, Apretude, PrEP, HPTN 083, HPTN 084
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,998 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, PPD Development, LP
- Study start
- 14 May 2024 (actual)
- Primary completion
- 14 Mar 2029 (estimated)
- Study completion
- 14 Mar 2029 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAB LA 600 mg (Q8W) | Experimental | Drug: CAB LAAll enrolled participants have previously received CAB LA as part of the HPTN 083 and HPTN 084 parent studies or their sub-studies. Participants will continue receiving CAB LA 600 mg via gluteal intramuscular (IM) injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Type of participant
- Participants must have recently completed or be currently enrolled and ongoing in one of the following studies on the CAB LA arm:
- Participants that completed study participation ≥3 months ago must be discussed with the Medical Monitor prior to enrolment.
- Participants who have prematurely withdrawn from prior CAB PrEP studies cannot enroll into this study.
- Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
Key exclusion criteria (20 listed)
- Concurrent conditions/medical history (includes liver function)
- Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor.
- Previous premature discontinuation from IP in the parent study/sub-study.
- ALT >5 × ULN; or ALT>3 × ULN and bilirubin >1.5 × ULN (with >35% direct bilirubin) in the screening liver chemistry test result.
- Participants with known active hepatitis B infection (as indicated by a positive HBsAg and/or quantifiable HBV DNA). Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAB LAAlso: Apretude, CAB LA for PrEPParticipants will receive CAB LA 600 mg via gluteal IM injection, once every 8 weeks (Q8W). | Drug | CAB LA 600 mg (Q8W) |
Primary outcome
Number of participants with new HIV infection
Time frame: From Day 1 up to end of study (up to approximately [approx.] 3 years)
Number of participants with new HIV infection by characteristic
Time frame: From Day 1 up to end of study (up to approx. 3 years)
Relevant characteristics of new HIV infections will be assessed, including presence of viral resistance to CAB.
3 secondary outcomes
Number of participants with serious adverse events (SAE) by severity
Time frame: From Day 1 up to end of study (up to approx. 3 years)
Number of participants with Grade 3 and Grade 4 injection site reactions (ISRs)
Time frame: From Day 1 up to end of study (up to approx. 3 years)
Number of participants with any clinical or laboratory AE leading to discontinuation of CAB LA, by severity
Time frame: From Day 1 up to end of study (up to approx. 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CAB LA in people with HIV Infections, run by ViiV Healthcare at 33 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in South Africa, Peru, Brazil, Zimbabwe, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with new HIV infection (time frame: From Day 1 up to end of study (up to approximately [approx.] 3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.