EUCTR2008-000604-88-GB进行中（未招募）不适用
A phase IV, two-arm, open-label, single-centre randomised pilot study to assess the feasibility of immeidate or deferred switching of HIV-infected individuals intolerant of efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir, to ritonavir-boosted darunavir - NNRTI/PI toxicity switch to darunavir study
St Stephen's Aids Trust0 个研究点目标入组 20 人开始时间: 2008年2月8日最近更新:
适应症
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
- 20
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 subject will be eligible for inclusion in the study only if ALL of the following criteria apply:
- •HIV-1 infected as documented by a licensed HIV-1 antibody ELISA test
- •The subject is currently on an antiretroviral regimen comprising at least three licensed antiretroviral agents including efavirenz, ritonavir-boosted lopinavir or ritonavir-boosted atazanavir
- •Symptomatic toxicity associated with the NNRTI/PI after at least 12 weeks of therapy
- •The subject is virologically suppressed with a viral load < 50 copies/ml
- •The subject has a CD4+ count above 50 cells/ml
- •If the subject is a woman of child bearing potential, she must agree to use a barrier method of contraception
- •No previous exposure to Darunavir
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will be eligible for inclusion in the study only if NONE of the following criteria apply:
- •1.Pregnant or lactating women
- •2.Any female subject of childbearing potential not using effective birth control methods or not 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: Hormone-based contraception may not be reliable when taking investigational agents; therefore, to be eligible for this trial, women of childbearing potential should either:
- •?Use a double barrier method to prevent pregnancy (i.e., using a condom with either spermicidal cream/foam/gel or diaphragm or cervical cap);
- •?Use hormone-based contraceptive in combination with a barrier contraceptive (i.e. male condom, diaphragm, or cervical cap with spermicide),
- •?Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, or cervical cap with spermicide),
- •?Do not engage in heterosexual sex, or have a vasectomised partner with confirmed sterility
- •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
- •Note: Spermicides containing non-oxynol-9 should not be used as this can potentially increase the rate of HIV-1 transmission
- •Note: Use of an IUD can increase the risk of sexually transmitted infections, including HIV
- •3.Heterosexually active male subject not using effective birth control methods or not willing to continue practising these birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational ARVs)
研究者
相似试验
进行中（未招募）
1 期
A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone StudyEUCTR2004-000337-12-HUSerono International SA400
进行中（未招募）
1 期
Study of quality of life in chronic Spontaneous Urticaria patients and treated by omalizumab (Xolair®)chronic spontaneous urticariaMedDRA version: 18.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2014-005424-97-FROVARTIS PHARMA SAS126
进行中（未招募）
1 期
SSAT046 Addition of Maraviroc to monotherapy Darunavir/Ritonavir studyHIVEUCTR2012-000649-11-GBSt Stephen's Aids Trust19
进行中（未招募）
不适用
SSAT046 Addition of Maraviroc to monotherapy Darunavir/Ritonavir studyEUCTR2012-000649-11-ESSt Stephen's AIDS Trust40
进行中（未招募）
4 期
A clinical trial to study effects of Denosumab in the Treatment of Postmenopausal Osteoporosis.CTRI/2023/05/052831Enzene Biosciences Limited