A Randomized, Controlled Trial to Evaluate the Efficacy of Substituting Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors in Individuals With Virologic Suppression for at Least 12 Weeks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- The Percentage of Participants With Successful Virologic Suppression
研究概览
简要总结
This study will evaluate patients who have achieved virologic suppression (< 400 copies/mL) on any dual protease inhibitor (PI) combination, to determine whether patients can substitute both PIs with the single boosted PI darunavir given 600/100 ritonavir (RTV) twice daily (BID) and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks.
详细描述
The purpose of this study is to determine if patients who have achieved virologic suppression (< 400 copies/mL) on any dual PI combination, can substitute both PIs with the single boosted PI darunavir given 600/100 rtv bid and maintain comparable virologic suppression (% < 50 c/mL) for 24 weeks. Randomized, non-blinded, multicenter, 48 week, controlled trial to assess the non-inferiority of substituting DRV/r for a dual boosted PI combination in patients with stable virologic suppression on a regimen containing a dual boosted PI combination plus at least one additional FDA-licensed antiretroviral agent from another class. Participants will be randomized (1:1) to one of the included treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Treatment with a stable antiretroviral regimen containing two protease inhibitors, one additional FDA-licensed agent from another class (except NNRTIs) and a boosting dosage of ritonavir (100 BID or QD) for at least 12 weeks prior to screening
- •No plans to make any changes in HIV treatment regimen (other than those required by study) in the next 48 weeks.
- •HIV-1 RNA < 400 copies/ml based on the most recent value done as part of routine care at least 12 weeks prior to screening; and < 400 at screening
- •Any CD4 count is allowed
- •Written informed consent to participate
排除标准
- •Current regimen includes an NNRTI
- •CDC Class C Illness diagnosed within 30 days of screening
- •Lab abnormalities as defined by a standardized grading scheme based on the DAIDS table
- •Any grade 3 or 4 toxicity with the following exceptions:
- •Pre-existing diabetes with glucose elevations ≥ grade 3
- •triglyceride or total cholesterol elevations ≥ grade 3
- •Clinical or laboratory evidence of clinically significant liver impairment/dysfunction, disease or cirrhosis Note: Individuals co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase.
- •Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance.
- •Use of any investigational agents 30 days prior to screening
- •Life expectancy < 6 months in the opinion of the investigator
- •Prior use of darunavir or known allergy to any of the components of darunavir
- •Breast feeding
- •Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
- •Note: Hormonal based contraception may not be reliable when taking darunavir, therefore to be eligible for this study, women of childbearing potential who may have vaginal intercourse should either:
- •Use a double barrier method to prevent pregnancy (i.e., using a condom with either a diaphragm or cervical cap) Or
- •Use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) Or
- •Use an intra uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, cervical cap or female condom) Or
- •Be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).
研究组 & 干预措施
Switch to DRV/r
Switch to DRV/r at a dose of 600/100 BID for 48 weeks
干预措施: Darunavir (DRV/r) (Drug)
Continue on Current Dual Boosted PI
Continue on current dual boosted PI until week 24. At week 24, participants will be allowed to cross over to the DRV/r arm provided that they have maintained virologic suppression (< 400 copies/ml) for the first 24-weeks of the study and are followed for an additional 24 weeks
干预措施: continue on current dual boosted PI (Drug)
结局指标
主要结局
The Percentage of Participants With Successful Virologic Suppression
时间窗: 24 weeks
Amount of HIV RNA copies per ml blood collected from subjects as measured by the Ultra-sensitive HIV-1 PCR (Roche Cobas). Successful virologic suppression is defined as \< 50 copies/ml blood. The result is the percentage of participants with successful virologic suppression.
次要结局
- Economic Impact of a Substitution of Dual Boosted PIs With DRV/r(48 weeks)
- Lipid Fraction Results, Mean of the Change From Baseline to Week 24.(baseline and 24 weeks)
- Treatment Satisfaction (+3, Much More Satisfied Now to -3, Much Less Satisfied Now)(24 weeks)