EUCTR2012-000649-11-ES进行中（未招募）不适用
A phase IV, openlabel, single centre, singlearm, pilot study to assess Cerebrospinal fluid INflammatory markers after Addition of Maraviroc to MONotherapy darunavir/ritonavir ? The CINAMMON Study SSAT046
St Stephen's AIDS Trust0 个研究点目标入组 40 人开始时间: 2014年3月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •1. male or female aged between 18 and 65 years
- •2. has a documented HIV-1 infection
- •3. has signed the Informed Consent Form voluntarily
- •4. is willing to comply with the protocol requirements
- •5. has an HIV-plasma viral load at screening <40 copies/mL (one off retesting for blips <200 copies/ml is allowed)
- •6. has a CD4 cell count at Screening >200 cells/mm3
- •7. has been on a stable darunavir/ritonavir regimen 800/100 once daily alone for at least 12 weeks at Screening, and willing to remain on this;
- •8. estimated glomerular filtration rate (by MDRD or CG methods) >60 ml/min at screening
- •9. CCR5 tropic by geno2pheno assay performed at screening
- •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);
- •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 continue 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. is infected with HIV-2
- •2. is using any concomitant therapy disallowed as per SPC for the study drugs (section 5.2)
- •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 Investigator 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
- •Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed
- •4. has acute viral hepatitis including, but not limited to, A, B, or C
- •5. has chronic hepatitis B and/or C
- •6. has received any investigational drug within 30 days prior to the trial drug administration
- •7. Clinically significant allergy or hypersensitivity to any trial medication excipients
- •8. If female, she is pregnant or breastfeeding
- •9. 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).
- •10. Clinical or laboratory evidence of significantly decreased hepatic function or decompensation: INR > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN.
- •11. Platelets of < 50 based on screening blood results.
- •12. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator?s opinion, interfere with assessments or completion of the trial.
研究者
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