Phase 3 study for people with HIV and AIDS
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| GSK Investigational Site | Darlinghurst | NSW | Recruiting |
| GSK Investigational Site | Sydney | NSW | Recruiting |
| GSK Investigational Site | Taringa | QLD | Recruiting |
| GSK Investigational Site | Perth | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion criteria:
Patient Study Participant (PSP) Inclusion criteria:
* Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg.
* Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening.
* HIV-1 RNA \<50 copies/mL at screening assessment.
* Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
* Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).
Exclusion criteria:
Patient Study Participant (PSP) Exclusion criteria:
* Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
* Any history of receiving long-acting therapy for HIV.
* Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection.
* Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 28 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.