NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080225332

Registered date:24/08/2020

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (SOLAR)

Basic Information

Recruitment status completed
Health condition(s) or Problem(s) studiedHIV-1 Infection
Date of first enrollment30/10/2020
Target sample size688
Countries of recruitmentAustralia,Austria,Belgium,Canada,France,Germany,Ireland,Italy,Netherlands,Spain,Swizerland,United Kingdom,United States
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : INN of investigational material : Cabotegravir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Rilpivirine Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Cabotegravir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Rilpivirine Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : Bictegravir/emtricitabine/tenofovir alafenamide Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcomeefficacy 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 Outcomesafety 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, Bother of ISRs, Leg movement, Sleep) and individual item scores (assessing pain during injection, anxiety before and after injection, willingness to be injected in the future and overall satisfaction with mode of administration over time) will be assessed using the Perception of injection questionnaire (PIN) at Months 2, 6, and 12 (OLI)/Months 1, 5, 11 (D2I) (or Withdrawal) -Incidence and severity of AEs and laboratory abnormalities over time including Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I). -Proportion of participants who discontinue treatment due to AEs over time including Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I). -Change from Baseline in laboratory parameters over time including Month 6 and Month 12 (OLI and BIK)/Month 5 and Month 11 (D2I).

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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.
Exclude 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.

Related Information

Contact

Public contact
Name Yasutoshi Okawa
Address Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
Telephone +81-120-561-007
E-mail jp.gskjrct@gsk.com
Affiliation GlaxoSmithKline K.K.
Scientific contact
Name Yasutoshi Okawa
Address Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
Telephone +81-120-561-007
E-mail jp.gskjrct@gsk.com
Affiliation GlaxoSmithKline K.K.