A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants
CompletedPhase 3Results postedLast updated 18 September 2023
What this trial tests
Phase 3 trial testing Cabotegravir Injectable Suspension in Human Immunodeficiency Virus Type 1 (HIV-1) in 118 participants. Completed in 23 August 2022.
18 and older, any sex, with Human Immunodeficiency Virus Type 1 (HIV-1). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8WPrimary· Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis.
Group
Value
95% CI
CAB+RPV Q8W First Thigh Injection
1.67
± 69.3
CAB+RPV Q8W Last Thigh Injection
1.61
± 55.5
CAB+RPV Q8W Pre-Thigh Gluteal Injection
1.81
± 51.6
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8WPrimary· Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q8W First Thigh Injection
103
± 49.7
CAB+RPV Q8W Last Thigh Injection
117
± 54.1
CAB+RPV Q8W Pre-Thigh Gluteal Injection
104
± 41.5
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8WPrimary· Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q8W First Thigh Injection
4.52
± 37.7
CAB+RPV Q8W Last Thigh Injection
3.70
± 40.8
CAB+RPV Q8W Pre-Thigh Gluteal Injection
3.36
± 41.4
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8WPrimary· Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q8W First Thigh Injection
184
± 33.9
CAB+RPV Q8W Last Thigh Injection
172
± 47.4
CAB+RPV Q8W Pre-Thigh Gluteal Injection
146
± 56.5
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8WPrimary· Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q8W First Thigh Injection
4038
± 34.6
CAB+RPV Q8W Last Thigh Injection
3384
± 36.6
CAB+RPV Q8W Pre-Thigh Gluteal Injection
3344
± 32.9
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8WPrimary· Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q8W First Thigh Injection
179483
± 33.8
CAB+RPV Q8W Last Thigh Injection
190641
± 50.4
CAB+RPV Q8W Pre-Thigh Gluteal Injection
162046
± 36.7
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4WPrimary· Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q4W First Thigh Injection
3.34
± 34.6
CAB+RPV Q4W Last Thigh Injection
3.00
± 37.8
CAB+RPV Q4W Pre-Thigh Gluteal Injection
2.94
± 38.9
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4WPrimary· Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q4W First Thigh Injection
170
± 35.2
CAB+RPV Q4W Last Thigh Injection
171
± 39.8
CAB+RPV Q4W Pre-Thigh Gluteal Injection
162
± 37.6
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4WPrimary· Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q4W First Thigh Injection
4.65
± 38.3
CAB+RPV Q4W Last Thigh Injection
4.09
± 35.6
CAB+RPV Q4W Pre-Thigh Gluteal Injection
3.95
± 35.8
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4WPrimary· Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q4W First Thigh Injection
210
± 34.9
CAB+RPV Q4W Last Thigh Injection
205
± 34.8
CAB+RPV Q4W Pre-Thigh Gluteal Injection
197
± 33.8
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4WPrimary· Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q4W First Thigh Injection
2558
± 34.4
CAB+RPV Q4W Last Thigh Injection
2379
± 34.8
CAB+RPV Q4W Pre-Thigh Gluteal Injection
2275
± 35.1
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4WPrimary· Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)
Blood samples were collected for PK analysis.
Group
Value
95% CI
CAB+RPV Q4W First Thigh Injection
120963
± 32.6
CAB+RPV Q4W Last Thigh Injection
123197
± 33.6
CAB+RPV Q4W Pre-Thigh Gluteal Injection
115202
± 33.9
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection Phase
Serious: 0/54 (0%)
Deaths: 0/54
CAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection Phase
Serious: 0/64 (0%)
Deaths: 0/64
CAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection Phase
Serious: 1/51 (2%)
Deaths: 0/51
CAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase
This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M \[A2M\]) study (NCT03299049).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other trials of Cabotegravir Injectable Suspension
Trials testing the same drug.
NCT05549726 — SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
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· completed
NCT06405464 — Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Tr
· recruiting
NCT03299049 — Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Hu
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· active not recruiting
Other ViiV Healthcare trials
Trials by the same sponsor.
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NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
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NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
· Phase 1, PHASE2
· not yet recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
· Phase 2
· recruiting
NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir
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Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 18 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05896761.