NCT00207142已完成4 期
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
研究概览
简要总结
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.
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
- •Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).
- •Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
- •Subjects who have a CD4 count ≥ 50 cells/mm
- •Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
- •Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives
排除标准
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- •WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
- •Primary HIV infection
- •Medical History and Concurrent Diseases
- •Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
- •Screening laboratory values measured as follows:
- •Grade IV glucose,
- •Grade IV electrolytes,
- •Grade IV transaminases,
- •Grade IV hematology.
- •Hypersensitivity to any component of the formulation of study drug
- •Prior history of taking any ARV for more than 10 days
- •Concomitant administration of tenofovir (TDF).
- •Refer to Section 6.4.1 which details all prohibited therapies
研究组 & 干预措施
Switch
Active Comparator
ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)
干预措施: Atazanavir + 2 NRTIs (Drug)
Continuation
Active Comparator
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
干预措施: Atazanavir + Ritonavir + 2 NRTIs (Drug)
Rescue
Other
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
干预措施: Atazanavir + Ritonavir + 2 NRTIs (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
时间窗: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA. Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48. Denominator included all randomized participants.
次要结局
- Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase(From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase)
- Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase(Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48)
- Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase(Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48)
- Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase(End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase)
- Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase(Baseline, Week 24 of Induction Phase)
- Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase(Baseline, Week 48 of Rescue Phase)
- Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase(Baseline, Week 24 of Induction Phase)
- Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase(\Baseline, Week 48 of Rescue Phase)
- Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase(Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.)
- Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase(Week 16-18, Week 24-26, Week 38-40, Week 64-66)
- Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase(Week 16-18, Week 24-26, Week 30-32)
- Summary of Adverse Events During Induction Phase(Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).)
- Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase(Baseline, Week 48 of Rescue Phase)
- Summary of Adverse Events During Maintenance Phase(Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.)
- Summary of Adverse Events During Rescue Phase(Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.)
- Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase(Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.)
研究者
研究点 (1)
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