A Study on ART Naïve Patients On Different Regimens to Treat Hiv (a Phase 4 Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Intention to treat (ITT)/time to loss of virological response (TLOVR)
研究概览
简要总结
The present study aims to compare efficacy, side-effects, and treatment adherence of three different treatment regimens given to antiretroviral naïve HIV-1 infected patients. Treatment will be initiated in accordance with the Swedish National Guidelines. In the twice daily (BID) arm (1), which could be considered as a standard regimen at present, lopinavir/ritonavir, is co-administrated with 2 nucleoside reverse transcriptase inhibitors (NRTIs) administrated BID. The first once daily (QD) arm (2) combines the protease inhibitor (PI) atazanavir/ritonavir with 2 NRTIs administrated QD, and in the second QD arm (3), the non nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz is combined with 2 NRTIs administrated QD. All drugs used in the study are licensed in the participating countries and patients will be followed as in clinical practice. Patients could optionally, after informed consent, be followed with additional measurements of HIV-1 RNA after 1, 2, and 3 weeks of treatment to asses the kinetics of viral decline after initiation of treatment.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 16 years of age
- •HIV-1 infected as documented by a licensed HIV-1 antibody ELISA
- •Ability to understand and provide informed consent
- •Indication for antiretroviral treatment
- •Antiretroviral naïve
- •All clinical laboratory values not clinically significant
排除标准
- •Subjects being pregnant
- •Women of childbearing potential not practicing birth control
- •Subjects with renal failure requiring dialysis
- •Drug interactions with any of the study drugs that are not manageable
- •Resistance to any of the study drugs
研究组 & 干预措施
lopinavir/ritonavir
400/100 mg BID + 2 NRTIs BID
干预措施: Lopinavir ritonavir (Drug)
atazanavir/ritonavir
300mg+100mg QD+ 2 NRTI QD
干预措施: Atazanavir ritonavir (Drug)
efavirenz
600mg QD + 2NRTI QD
干预措施: Efavirenz (Drug)
结局指标
主要结局
Intention to treat (ITT)/time to loss of virological response (TLOVR)
时间窗: 144 weeks
1. Virological failure (see 5.5.2 for definition) 2. Treatment interruption or change of study treatment due to side-effects 3. Treatment interruption or change of study treatment due to any other reason 4. Missed to follow-up 1. HIV-1 RNA \>50 copies/ml in two consecutive measurements from week 24 and on 2. any rise in HIV-1 RNA \>50 copies/ml in two consecutive measurements after viral load \<50 copies/ml has been reached 3. HIV-1 RNA never \<50 copies/ml after week 24
次要结局
- Frequency of abnormal laboratory parameters(144 weeks)
- Adherence to study medication(144 weeks)
- Frequency of adverse events(144 weeks)
- Changes in CD4 cell counts(144 weeks)
- Changes in plasma lipids(144 weeks)
- Frequency of hyperlipidemia(144 weeks)
研究者
Lars-Magnus Andersson
Principal Investigator
Göteborg University