HIV-1 Infection
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : Cabotegravir
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older (or >-19 where required by local regulatory agencies), at the time of signing the informed consent. 2. A female participant is eligible to participate if she is not pregnant, not lactating. 3. Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. 4. Plasma HIV-1 RNA <50 c/mL in the 6 months prior to Screening and at Screening.
Exclusion criteria
Exclusion criteria: -Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >-50 c/mL -Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements >-50 c/mL. -History of prior treatment failure to any DHHS recommended ART regimen. -Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study. -Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/mL are not exclusionary. -Participants with moderate to severe hepatic impairment. -History of liver cirrhosis with or without hepatitis viral co-infection. -Ongoing or clinically relevant pancreatitis. -Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia. -Known or suspected presence of resistance mutations as defined by the IAS-USA resistance guidelines to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any historical resistance test result.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Proportion of participants with plasma HIV-RNA greater than or equal to 50 copies/mL as per Food and Drug Administration (FDA) Snapshot algorithm at Month 12 (OLI and BIK)/Month 11 (D2I) (Intent-to-Treat Exposed [ITT-E] population) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Proportion of participants with plasma HIV-1 RNA <50 c/mL (c/mL) at Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I) using the FDA Snapshot algorithm (Intent-to-Treat Exposed [ITT-E] population) -Proportion of participants with protocol-defined confirmed virologic failure (CVF) through Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I). -Proportion of participants with HIV-RNA greater than or equal to 50 c/mL as per FDA Snapshot algorithm at Month 6, and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I) -Absolute values and changes from Baseline in viral load and CD4+ cell count over time including Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I) -Incidence of treatment emergent genotypic and phenotypic resistance to CAB, RPV, BIC, FTC, and TAF through Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I). -Change from Baseline (Day 1) in renal and bone biomarkers at Months 6 and 12 (OLI and BIK)/Month 5 and Month 11 (D2I). -Change from Baseline in proportions of participants with Metabolic syndrome at Months 6 and 12 (OLI and BIK)/Month 5 and Month 11 (D2I) -Change from Baseline (Day 1) in homeostasis model of assessment-insulin resistance (HOMA-IR) at Months 6 and 12 (OLI and BIK)/Month 5 and Month 11 (D2I). -Preference for CAB LA + RPV LA every 2 months compared to a BIK single tablet regimen will be assessed using a preference questionnaire at Month 12 (OLI)/Month 11 (D2I) (or Withdrawal). -Change from baseline (Day 1) in total treatment satisfaction score, and individual item scores of the HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) at Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I), (or Withdrawal) -Change in treatment satisfaction over time using the HIV Treatment Satisfaction Change Questionnaire HIVTSQc total score and individual item scores at Month 12 (OLI and BIK)/Month 11 (D2I) (or Withdrawal). -Change from Month 2 in Dimension scores (Acceptance of ISRs, | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Swizerland, United Kingdom, United States
Contacts
Public ContactYasutoshi Okawa
GlaxoSmithKline K.K.
Outcome results
None listed