NCT04826562进行中（未招募）4 期
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Virologic Failure
研究概览
简要总结
An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV-1 infection
- •Age of 18 years or older
- •On Biktarvy for at >24 weeks with HIV viral load < 50 copies /mL for > 6 months immediately prior to enrollment
- •Agree to consistently use an effective method of contraception (see Appendix: Highly Effective Methods for Avoiding Pregnancies in Females of Reproductive Potential) for women of child-bearing potential
- •Willingness to sign the informed consent
- •If history of virologic failure must be fully suppressed (HIV-1 RNA<50 copies/mL) for at least 12 months before screening visit
- •No prior HIV genotype or phenotype available
排除标准
- •Hypersensitivity to dolutegravir and/or lamivudine
- •History of virologic failure while on an integrase inhibitor
- •Taking any medication contraindicated for co-administration with dolutegravir and/or lamivudine according to manufacturer's current medication package inserts
- •HIV-1 RNA ≥50 copies/mL (confirmed) in the past 48 weeks after initial suppression on therapy to HIV-1 RNA <50 copies/mL
- •Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
- •Participants positive for HBsAg are excluded.
- •Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
- •Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. Anti-HBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM. Participants with a documented history of chronic HBV and current undetectable HBV DNA while on a Biktarvy are excluded.
- •Pregnant women, women actively seeking to become pregnant, and women of child-bearing potential who are not using effective contraception
- •Severe hepatic impairment (Child-Pugh C)
- •Critically ill and/or unable to take oral medications
- •Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe for the subject
- •Creatinine clearance < 30 mL/min/1.73m2 via CKD-EPI method
- •ALT > 5x the upper limit of normal (ULN) or ALT > 3x ULN and total bilbirubin >1.5x ULN (and >35% directed bilirubin)
- •Subjects with an anticipated need for hepatitis C virus therapy with interferon and/or ribavirin prior to the primary endpoint
- •Unstable liver disease, cirrhosis, and/or known biliary abnormalities (except for hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)
研究组 & 干预措施
dolutegravir/lamivudine
Experimental
dolutegravir/lamivudine
干预措施: Dolutegravir/Lamivudine (Drug)
结局指标
主要结局
Virologic Failure
时间窗: 48 weeks
To determine the % of virologic failures (VL ≥ 50 copies/mL at week 48 using the FDA ITT, Snapshot analysis
次要结局
- Virologic Suprresion(96 weeks)
- Retrospective Baseline Resistance(96 weeks)
研究者
Jihad Slim, MD
Chief of Infectious Diseases
Saint Michael's Medical Center
研究点 (1)
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