Human Immunodeficiency Virus Type 1 (HIV-1) MedDRA version: 20.1 Level: LLT Classification code 10003582 Term: Asymptomatic human immunodeficiency virus type I infection System Organ Class: 100000004862
Conditions
Sponsors
Viiv Healthcare UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A participant will be eligible for inclusion in this study only if all the following criteria are met: • Be able to understand and comply with protocol requirements, instructions, and restrictions; • Understand the long-term commitment to the study and be likely to complete the study as planned; • Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.). • if he/she meets all eligibility criteria and for whom an individual benefit can be expected. Source documentation to verify entry criteria must be reviewed by the Principal Investigator or designee prior to enrolment. Source documents from other medical facilities must be located/received during the 35-day screening phase and under no circumstances may the participant be enrolled in the absence of source documentation. AGE 1. Aged 18 years or older at the time of signing the informed consent. TYPE OF PARTICIPANT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. HIV-1 infected and must be suppressed on a guideline recommended active HAART regimen for at least 6 months prior to Screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic failure (on treatment HIV-1 RNA =200 c/mL). 3. Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: at least one < 6 months prior to Screening and one 6-12 months prior to screening; 4. Plasma HIV-1 RNA <50 c/mL at Screening; SEX 5. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test at screen and at Day 1), not lactating, and at least one of the following conditions applies: a. Non-reproductive potential defined as: Pre-menopausal females with one of the following: -Documented tubal ligation -Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion -Hysterectomy -Documented Bilateral Oophorectomy -Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (Section 10.7) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. INFORMED CONS
Exclusion criteria
Exclusion criteria: HIV-1 RNA 1. Within 6 months prior to Screening, plasma HIV-1 RNA measurement =50 c/mL; 2. During the previous 12 months, any confirmed HIV-1 RNA measurement =200 c/mL Exclusionary medical conditions 3. Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study. 4. 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 historical or current CD4+ counts 3.25 is exclusionary ii. Fib-4 scores 1.45 – 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: (Age x AST) / (Platelets x (sqr [ ALT ]) 12. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esopha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Staff Study Participants (SSP): To evaluate -acceptability -appropriateness -feasibility;Secondary Objective: Staff Study Participants: To evaluate -Facilitators to implementation -Barriers to implementation -Adaptations/Modifications to address barriers and facilitators Patient Study Participants (PSP) To evaluate -Facilitators to implementation -Barriers to Implementation To evaluate Patient Study Participants experience of delivering CAB LA + RPV LA, including -Acceptability -Appropriateness -Feasibility To evaluate sustainability of CAB LA + RPV LA with Study Staff Participants each clinic To assess fidelity to CAB LA + RPV LA injection dosing windows Evaluate efficacy and safety measures of CAB LA + RPV LA To assess preference between CABLA + RPV LA and oral ART medication received prior to entering the study ;Primary end point(s): Staff Study Participants (SSP): 1)Change of Acceptability of Implementation Measure Score, Implementation Appropriateness Measure Score, Feasibility of Implementation Measure Score over time assessed quantitatively. 2)Semi-structured interviews (SSIs) assessed qualitatively. ;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Staff Study Participants: 1)Change of Implementation Leadership Scale, Change of Implementation Climate Scale over time assessed quantitatively via questionnaires through Month 12. 2)Summarize components from Enhanced Implementation & Standard Implementation via FRAME-IS outcome Months 2 – 12 (monthly) 3)Summarize components from Enhanced Implementation via CQI 1-hour calls/PDSAs minimum of Months 2-7 (monthly) 4)SSIs assessed qualitatively through Month 12. 5)Total score of the Clinical Sustainability Assessment Tool (CSAT) at Month 12. Patient Study Participants (PSP) 1)Questionnaires assessed quantitatively through Dose 7.b 2)Length of patient study participant visit from arrival until departure from clinic assessed at Dose 1, Dose 2, Dose 4, and Dose 5. 3)SSIs assessed qualitatively through Dose 7. 4)Change in Acceptability of Intervention Measure Score, Intervention Appropriateness Measure Score, and Feasibility of Intervention Measure Score over time. Assessed via questionnaires at Dose 7. b 5)SSIs assessed qualitatively through Dose 7. Efficacy Safety and Other Endpoints: 1)Percentage of injections occurring within target window from the target date. 2)Proportion of participants with plasma HIV-1 RNA <50 c/mL over time. 3)Proportion of participants with confirmed virologic failure (CVF) over time 4)Incidence of treatment-emergent genotypic and phenotypic resistance to CAB and RPV in patient study participants with CVF 5)Incidence and severity of AEs, SAEs and proportion of participants who discontinue treatment due to AEs over time 6)Preference between CAB + RPV LA and daily oral ART medication (received prior to entering the study) at quantitatively assessed via preference questionnaire at Dose 7 ;Timepoint(s) of evaluation of this end point: Month 12/Dose 7 or otherwise stated | — |
Countries
Belgium, France, Germany, Netherlands, Spain
Contacts
Public ContactClinical Trials Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed