EUCTR2014-004578-40-GB进行中（未招募）1 期
A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal tubular function and renal transporters in HIV-1 antiretroviral naïve patients - SSAT066 Renal Integrase Study
St Stephen's AIDS Trust0 个研究点目标入组 60 人开始时间: 2016年1月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
入选标准
- •Patient volunteers who meet all of the following criteria are eligible for this trial:
- •1. Is male or female aged 18 years or above
- •2. Has documented HIV-1 infection
- •3. Has signed the Informed Consent Form voluntarily
- •4. Is willing to comply with the protocol requirements, including dosing schedules of each regimen
- •5. Has a HIV-plasma viral load at screening >1000 copies/mL
- •6. Has any CD4 cell count
- •7. Has never been exposed to ART (other than via PEP or PREP, not associated with acquisition of HIV)
- •8. Has an estimated glomerular filtration rate (MDRD method) >60 ml/min
- •9. Has no known resistance to TDF and FTC or to Integrase Inhibitors. HIV resistance test has to be dated no more than 1 year prior screening date. Only a RT/Pr gene resistance test is re-quired.
- •10. If female and of childbearing potential, she is using effective birth control methods (as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs); Dosing of the OCP may need to be adjusted if randomized to the Stribild® arm.
- •Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
- •11. If a heterosexually active male, he is using effective birth control methods and is willing to con-tinue practising these birth control methods during the trial and until follow-up visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients meeting 1 or more of the following criteria cannot be selected:
- •1. Is infected with HIV-2
- •2. Is using any concomitant therapy disallowed as per SPC for the study drugs
- •3. Has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection-1993) with the following exceptions (must be discussed with the sponsor prior to enrolment):
- •? Stable cutaneous Kaposi’s Sarcoma (no pulmonary or gastrointestinal involvement other than oral lesions) unlikely to require systemic therapy during the trial period
- •? CD4 count less than 200 cells/mm3
- •Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed
- •4. Has diabetes or any known or established renal disease or abnormality regardless of if stable
- •5.Has presence at screening of proteinurea and or a urinary protein/creatinine ratio >30
- •6.Has untreated / not well controlled hypertension
- •7. Has acute viral hepatitis including, but not limited to, A, B, or C
- •8. Has chronic hepatitis B or chronic hepatitis C with AST and/or ALT >5 x ULN
- •Note: Subjects co-infected with chronic HCV (but not B) can enter the trial if clinically stable and not expected to require treatment during the trial period.
- •9. Has received any investigational drug within 30 days prior to the trial drug administration
- •10. No baseline resistance test to reverse transcriptase inhibitors available
- •11. Clinically significant allergy or hypersensitivity or other contraindication to any trial medication or excipients
- •12. If female, she is pregnant or breastfeeding
- •13. Screening blood results with any grade 3 / 4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
- •12. Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L
- •14. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
- •15. Is not using high protein training supplements such as creatinine or intermittently following exclusionary or high protein diets
- •16. Is not receiving medication with known relevant drug interactions or contraindications to any of the trial medications
- •17. Has untreated/not well controlled hypertension (values of BP consistently > 150/95 mmHg).
研究者
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