A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed
- Conditions
- Human Immunodeficiency Virus Type-1HIV-1 Infection10047438
- Registration Number
- NL-OMON54886
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
- 18 years or older
- Women not pregnant, not lactating, or having a Non-reproductive potential or
Postmenopausal
- 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. Only a single prior INI regimen is allowed if BIK is a second line
regimen > 6 months prior to screening.
- Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6
months prior to Screening.
- Plasma HIV-1 RNA <50 c/mL at Screening.
1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement
50 c/mL
2. Within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA
measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements
50 c/mL.
3. History of prior treatment failure to any DHHS recommended ART regimen.
4. History of drug holiday >1 month for any reason prior to Screening visit,
except
where all ART was stopped due to tolerability and/or safety concerns
5. Any change to a second line regimen
7. Women who are pregnant, breastfeeding or plan to become pregnant or
breastfeed
during the study
8. Any evidence of a current Center for Disease Control and Prevention (CDC)
Stage 3 disease, except cutaneous Kaposi*s sarcoma not requiring systemic
therapy, and CD4+ counts <200 cells/mm3L are not exclusionary.
9. Participants with moderate to severe hepatic impairment
10. Any pre-existing physical or mental condition (including substance use
disorder)
which, in the opinion of the Investigator, may interfere with the participant*s
ability to comply with the dosing schedule and/or protocol evaluations or which
may compromise the safety of the participant
11. Participants with a high risk of seizures, including participants with an
unstable or poorly controlled seizure disorder.
12. Untreated secondary (late latent) or tertiary syphilis infection, defined
as a positive RPR and a positive treponemal test without clear documentation of
treatment
13. Participants who pose a significant suicide risk.
14. The participant has a tattoo, gluteal implant/enhancements or other
dermatological
condition overlying the gluteus region which may interfere with interpretation
of
injection site reactions
15. Evidence of Hepatitis B virus (HBV) infection
16. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection
will not
be excluded
17. Unstable liver disease
18. History of liver cirrhosis with or without hepatitis viral co-infection.
19. Ongoing or clinically relevant pancreatitis
20. Clinically significant cardiovascular disease
21. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell
carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or
cervical intraepithelial neoplasia;
22. Any condition which, may interfere with the absorption, distribution,
metabolism or excretion of the study drugs or render the participant unable to
receive study medication
23. History or presence of allergy or intolerance to the study drugs or their
components or drugs of their class.
24. Current or anticipated need for chronic anti-coagulation
25. Corrected QT interval for subjects with bundle branch block.
26. Known or suspected active COVID-19 infection OR has had contact with an
individual with known COVID-19, within 14 days of study enrolment.
27. Known or suspected presence of resistance mutations as defined by the
IAS-USA
to the individual components of BIK (BIC, FTC, TAF), RPV, and CAB by any
historical resistance test result.
28. Any verified Grade 4 laboratory abnormality.
29. Any acute laboratory abnormality at Screening
30. Participant has estimated creatine clearance <30mL/min per 1.73m2
31. Alanine aminotransferase (ALT) >=3 × ULN
32. Exposure to an experimental drug or experimental vaccine within either 30
days,
5
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every two<br /><br>months compared to a BIK single tablet regimen administered once daily:<br /><br>Proportion of participants with plasma HIV-RNA greater than or equal to 50<br /><br>copies/mL as per Food and Drug Administration (FDA) Snapshot algorithm at Month<br /><br>12 (OLI and BIK)/Month 11 (D2I) (Intent-to-Treat Exposed [ITT-E] population)</p><br>
- Secondary Outcome Measures
Name Time Method