NL-OMON54886已完成3 期
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 - 213500 - SOLAR
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- 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
- •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.
排除标准
- •1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement
- •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
- •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,
- •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
- •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
- •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
- •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
- •injection site reactions
- •15. Evidence of Hepatitis B virus (HBV) infection
- •16. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection
- •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
- •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
- 另有 3 项未显示
研究者
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