A Phase 3 interventional study of CAB ULA and RPV ULA in HIV, sponsored by ViiV Healthcare. Recruiting at 111 sites in 10 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).
ViiV Healthcare is the lead sponsor of 265 studies on the registry; 16 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 10, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient Study Participant (PSP) Inclusion criteria
Exclusion criteria:
Patient Study Participant (PSP) Exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive CAB ULA+RPV ULA.
Drug: CAB ULA · Drug: RPV ULA
Participants will receive CAB LA+RPV LA.
Drug: CAB LA · Drug: RPV LA
CAB ULA will be administered.
RPV ULA will be administered.
CAB LA will be administered.
RPV LA will be administered.
Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm
Time frame: At Month 11
Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm
Time frame: At Month 23
Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm
Time frame: At Month 11 and Month 23
Percentage of participants with confirmed virologic failure (CVF)
CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.
Time frame: Up to Month 11 and Month 23
Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Time frame: Up to Month 11 and Month 23
Number of participants with drug-related serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Time frame: Up to Month 11 and Month 23
Number of participants who discontinue treatment due to AEs or injection intolerability
Time frame: Up to Month 11 and Month 23
Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV
Time frame: Up to Month 23
Plasma concentrations of CAB and RPV
Time frame: Up to Month 23
Percentage of adolescent participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm
Time frame: At Month 11 and Month 23
Percentage of adolescent participants with plasma HIV-RNA < 50 c/mL as per FDA Snapshot algorithm
Time frame: At Month 11 and Month 23
Percentage of adolescent participants with confirmed virologic failure (CVF)
CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.
Time frame: Up to Month 11 and Month 23
Absolute value of Cluster of Differentiation 4 (CD4+) cell counts in adolescent participants
Time frame: Up to Month 11 and Month 23
Change from Baseline in CD4+ cell counts in adolescent participants
Time frame: At Month 11 and Month 23 compared to baseline (Day 1)
Number of adolescent participants with drug-related AEs as per severity of Grade 2-5
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Time frame: Up to Month 11 and Month 23
Number of adolescent participants with drug-related SAEs
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Time frame: Up to Month 11 and Month 23
Number of adolescent participants who discontinue treatment due to AEs or injection intolerability
Time frame: Up to Month 11 and Month 23
Showing the first 100 of 111 sites across 10 countries. Choose a country and city above to see the rest.
Plan to share: 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_28May2026.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.viiv-studyregister.com
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Aug 2029, 37 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Sep 2029 → Aug 2029 and completion Sep 2029 → Aug 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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