EUCTR2014-003052-31-PL进行中（未招募）1 期
A Phase 3, randomized, active-controlled, open-label study to evaluate the efficacy, safety and tolerability of switching to a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once-daily single-tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects.
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
- 1,100
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
- •- Currently being treated with a stable ARV regimen consisting of a bPI (limited to DRV
- •once daily with rtv or COBI, ATV with rtv or COBI, or LPV with rtv) combined with FTC/TDF only, for at least 6 consecutive months preceding the screening visit.
- •- Subjects treated with the combination DRV + COBI + FTC/TDF and having completed the
- •required visits in the GS-US-216-0130 study, and who are fulfilling the present protocol
- •criteria, will be given the option to participate in this study.
- •- Documented evidence of being virologically suppressed while on a stable ARV regimen
- •prior to screening: at least 1 plasma HIV-1 RNA measurement <50 copies/mL (or HIV-1
- •RNA undetectable by a local HIV-1 RNA test) occurring between 12 and 2 months prior to
- •the screening visit while on the stable ARV regimen and have HIV-1 RNA <50 copies/mL
- •at the screening visit.
- •- A single viral load elevation of =50 copies/mL and <200 HIV-1 RNA copies/mL after
- •previously reaching viral suppression (‘blip’) within 12 months prior to screening is
- •allowed, provided a subsequent viral load measurement is <50 HIV-1 RNA copies/mL
- •(or HIV-1 RNA undetectable by a local HIV-1 RNA test) prior to screening.
- •- Absence of history of failure on DRV treatment and absence of DRV RAMs (including
- •V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), if documented historical genotypes are available. If no historical genotype is available, the subject can be included, provided no previous failure on DRV treatment has been documented.
- •- Normal ECG at screening (or if abnormal, determined by the investigator to be not
- •clinically significant).
- •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 990
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. A new AIDS-defining condition diagnosed within the 30 days prior to screening.
- •2. Proven or suspected acute hepatitis within 30 days prior to screening.
- •3. Hepatitis C antibody positive; however, subjects spontaneously cured of hepatitis C virus (HCV) infection and subjects cured of HCV infection after treatment (with documented sustained virologic response, ie, undetectable HCV RNA 24 weeks after the last dose of HCV treatment), are allowed to participate.
- •4. Hepatitis B surface antigen (HBsAg) positive.
- •5. Subjects with history of cirrhosis as diagnosed based on local practices.
研究者
相似试验
进行中（未招募）
1 期
Study to Evaluate Efficacy of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected ParticipantsHuman Immunodeficiency Virus Type 1MedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-003052-31-ESJanssen R&D, Ireland660
进行中（未招募）
1 期
Study to Evaluate Efficacy, Safety and Tolerability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected subjectsEUCTR2014-003052-31-GBJanssen Science Ireland Unlimited Company1,100
进行中（未招募）
1 期
Study to Evaluate Efficacy, Safety and Tolerability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected subjectsHuman Immunodeficiency Virus Type 1MedDRA version: 18.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-003052-31-BEJanssen R&D, Ireland1,100
进行中（未招募）
1 期
Study to Evaluate Efficacy, Safety and Tolerability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected subjectsEUCTR2014-003052-31-SEJanssen Sciences Ireland UC1,100
进行中（未招募）
1 期
Study to Evaluate Efficacy of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected ParticipantsEUCTR2014-003052-31-FRJanssen R&D, Ireland660