HIV Infections
Conditions
Keywords
Cabotegravir, Rilpivirine, HIV, Non-inferiority, Efficacy, Safety, Tolerability
Brief summary
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).
Interventions
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | At Month 11 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm | At Month 23 | — |
| Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm | At Month 11 and Month 23 | — |
| Percentage of participants with confirmed virologic failure (CVF) | Up to Month 23 | CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL. |
| Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5 | Up to Month 23 | 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. |
| Number of participants with drug-related serious adverse events (SAEs) | Up to Month 23 | 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. |
| Number of participants who discontinue treatment due to AEs or injection intolerability | Up to Month 23 | — |
| Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV | Up to Month 23 | — |
| Ctrough of CAB and RPV | Up to Month 23 | — |
| Maximum concentrations post dose (Cmax) of CAB and RPV | Up to Month 23 | — |
| Area under the curve (AUC) of CAB and RPV | Up to Month 23 | — |
| Absolute value of CD4+ cell counts in participants | Up to Month 23 | — |
| Change from Baseline in CD4+ cell counts in participants | At Month 23 compared to baseline (Day 1) | — |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed