EUCTR2021-000290-84-ES进行中（未招募）1 期
Virologic Outcomes of Lamivudine/Dolutegravir in Virologically suppressed subjects with Expected or confirmed Resistance to Lamivudine (VOLVER study). - VOLVER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 117
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Adults (? 18 years old) with HIV-1 infection able to understand and give informed written consent.
- •b. Stable ART in the 12 weeks prior to screening visit.
- •- Only switch for tolerability/convenience/access reasons to generic drugs or switch from ritonavir to cobicistat or TDF to TAF would be allowed in the 12-week window and as long as the components of the regimen are unchanged.
- •c. Viral load <50 copies/mL at screening and in the year prior to study entry.
- •- A blip (50-500 copies/ml) would be allowed within 48 weeks prior to inclusion in the study, if preceded and followed by an undetectable VL determination.
- •d. CD4 count > 200 cel/µL at screening.
- •e. History of 3TC resistance: either confirmed historical 3TC resistance (historical RNA Sanger or RNA NGS>20% threshold genotype with M184V/I mutation) OR suspected historical 3TC resistance.
- •- Suspicion of past 3TC resistance is defined as any of the following:
- •i. Previous treatment with only 2 NRTIs (1 of them being emtricitabine or 3TC [XTC]).
- •ii. Two consecutive VL > 200 cp/mL while on treatment including XTC.
- •iii. One VL > 200 cp/mL while on treatment including XTC PLUS change of ART as consequence of that elevated VL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 117
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 117
排除标准
- •a. Participants with M184V/I or K65R in screening visit proviral DNA Sanger
- •b. Prior virologic failure (VF) under integrase inhibitor (INSTI)- based regimen.
- •defined as two consecutive VL > 200 copies/mL while receiving INSTI
- •regardless of genotypic test results
- •c. INSTI resistance mutations in historical RNA genotype.
- •d. Positive Surface Hepatitis B Ag (HBAgS) OR negative HBAgS and negative
- •hepatitis B surface antibody (anti-HBs) with positive anti-core antibody (anti-
- •HBc) and positive HBV DNA.
- •e. Pregnant, breastfeeding women, women with a positive pregnancy test at the
- •time of screening, sexually active fertile women wishing to conceive or unwilling
- •to commit to contraceptive methods (see Appendix 1 for the accepted list of the
- •highly effective methods for avoiding pregnancy), for the duration of the study
- •and until 4 weeks after the last dose of study medication. All women are
- •considered fertile unless they have undergone a sterilizing surgery or are over
- •the age of 50 with spontaneous amenorrhea for over 12 months prior to study
- •f. Patients with active opportunistic infections or cancer requiring intravenous
- •treatment and/or chemotherapy at screening.
- •g. Any comorbidities or treatment with experimental drugs that according to the
- •investigator could bias study results or entail additional risks for the participant.
- •h. Participants receiving other medications that according to study drug label are
- •contraindicated.
- •i. Severe hepatic impairment (Class C) as determined by Child-Pugh
- •classification.
- •j. Alanine aminotransferase (ALT) over 5 times the upper limit of normal (ULN) or
- •ALT over 3xULN and bilirubin over 1.5xULN.
- •k. Unstable liver disease (as defined by the presence of ascites, encephalopathy,
- •coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent
- •jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia
- •or jaundice due to Gilbert's syndrome or asymptomatic gallstones);
- •l. Creatinine clearance of <30 mL/min/1.73m2 via CKD-EPI method.
- •m. Any verified Grade 4 laboratory abnormality that to the investigators criteria
- •would affect the safety of the participant if included in the study.
- •n. History or presence of allergy to dolutegravir or lamivudine.
研究者
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