EUCTR2011-001646-16-BE进行中（未招募）1 期
A Dolutegravir Open Label Protocol for HIV infected, Adult and Adolescents Patients with Integrase Resistance
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •Male or female patients aged =12 years weighing >40kg
- •NOTE: all female patients of child-bearing potential should use every precaution to prevent pregnancy. Contraception guidelines include:
- •Complete abstinence from intercourse from 2 weeks prior to administration of DTG, throughout receipt of DTG, and for at least 2 weeks after discontinuation of DTG;
- •Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
- •Approved hormonal contraception;
- •Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion);
- •Male partner sterilization prior to the female patient’s entry into the study, and this male is the sole partner for that patient;
- •Any other method with published data showing that the expected failure rate is <1% per year.
- •Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IP.
- •All patients participating in the study should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g., male condom/spermicide).
- •Documented plasma HIV-1 RNA levels =400 copies/mL within 3 months prior to the Screening visit.Documented RAL or ELV resistance in the patient’s medical records (evidence of phenotypic and/or genotypic resistance must be provided to qualify for the EAP program). If resistance is not documented, Investigators may, at their own expense, test potential recruits.
- •Inability to construct a viable background regimen of ART with commercially available medications.
- •The patient/legal guardian or representative has given written informed consent to treatment prior to any program-specific assessments are initiated in accordance with country-specific regulatory authority requirements.
- •For patients enrolled in France: a patient will be eligible for inclusion in this study only if, either affiliated to or, a beneficiary of a social security category.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 990
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Deviations from exclusion criteria are not allowed because they can potentially jeopardize patient safety. Therefore, adherence to the criteria as specified in the protocol is essential.
- •Patients meeting any of the following criteria must not be enrolled in the program:
- •1. Patient has estimated creatinine clearance (CrCl) <30 mL/min via Cockcroft-Gault method [Cockcroft, 1976].
- •Calculated CrCl (mL/min) = (140 - age [years]) x weight (kg)/ [72 × serum creatinine (mg/100mL)]
- •Female patients: multiply by 0.85
- •In order to use SI units, the following formula may be used:
- •Calculated CrCl (mL/min) = (140 - age [years]) x weight (kg) x 1.23/serum creatinine (µmol/L)
- •Female patients: multiply by 0.85
- •2. Females who are pregnant or breastfeeding.
- •3. Patients who have had a known or suspected allergic reaction to an INI.
- •4. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) within 1 month of treatment initiation and/or at last ALT determination.
- •5. ALT >3 times ULN and total bilirubin >1.5 times ULN (with >35% direct bilirubin within 1 month of treatment initiation) and/or at last ALT and bilirubin determinations.
- •6. Evidence for severe hepatic impairment (Child-Pugh class C).
- •7. Patients who are eligible for, and have access to, an actively enrolling DTG Phase III/b clinical trial.
- •8. Any condition (including but not limited to alcohol and drug use) or any active clinically significant disease or findings during Screening of medical history or physical examination, which, in the opinion of the Investigator would interfere with patient safety or compliance.
- •9. Patient requires or is anticipated to require any of the prohibited concomitant therapy as listed in Section 5.6.2.
- •French patients recruited at sites in France will be excluded if the patient has participated in any study using an investigational drug during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to Screening for the study, or the patient will participate simultaneously in another clinical trial.
- •NOTE: Patients should not be considered for the EAP if they are eligible and able to participate in any of the clinical treatment trials of DTG in treatment-experienced patients (protocols ING111762, ING112961 or ING112574). Please refer to any national or local requirements for participation in EAPs. In that instance (assuming consent is obtained), the patient should preferentially be enrolled into the ongoing clinical trial to allow detailed data collection.
- •Physicians with patients who do not fit all criteria cited above yet have a significant unmet medical need may appeal to the ViiV Safety and Labelling Committee in order to secure access to DTG under this program.
- •Notwithstanding these minimum inclusion and exclusion criteria, Investigators must also follow country specific guidelines where they exist when making decisions about patients who are eligible for study participation.
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