NCT01309243已完成3 期
A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 799
- 试验地点
- 150
- 主要终点
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
研究概览
简要总结
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.
Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.
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
- •Ability to understand and sign a written informed consent form
- •Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening
- •No prior use of any approved or experimental anti-HIV drug for any length of time
- •Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y
- •Normal ECG
- •Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 5 x the upper limit of the normal range (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function
- •Serum amylase ≤ 5 x ULN (participants with serum amylase > 5 x ULN remained eligible if serum lipase was ≤ 5 x ULN)
- •Adequate renal function
- •Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks following the last dose of study drug.
- •Adult (≥ 18 years) males or non-pregnant females
排除标准
- •A new AIDS-defining condition diagnosed within the 30 days prior to screening
- •Females who were breastfeeding
- •Positive serum pregnancy test (female of childbearing potential)
- •Proven or suspected acute hepatitis in the 30 days prior to study entry
- •Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to receive treatment for hepatitis C during the course of the study
- •Subjects experiencing decompensated cirrhosis
- •Had an implanted defibrillator or pacemaker
- •Current alcohol or substance abuse
- •A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
- •Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- •Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens
- •Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial.
- •Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and other immune-based or cytokine-based therapies)
- •Had any other clinical condition or prior therapy that, in the opinion of the Investigator, would have made the participant unsuitable for the study or unable to comply with the dosing requirements
研究组 & 干预措施
FTC/RPV/TDF
Experimental
干预措施: FTC/RPV/TDF (Drug)
EFV/FTC/TDF
Experimental
干预措施: EFV/FTC/TDF (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
时间窗: Week 48
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
次要结局
- Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48(Baseline to Week 48)
- Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance(Baseline to Week 96)
- Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48(Baseline to Week 48)
- Development of HIV-1 Drug Resistance Through Week 96, All Participants(Baseline to Week 96)
- Change From Baseline in Fasting Triglycerides at Week 48(Baseline to Week 48)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96(Baseline to Week 96)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline to Week 48)
- Change From Baseline in CD4 Cell Count at Week 96(Baseline to Week 96)
- Change From Baseline in Fasting Total Cholesterol at Week 48(Baseline to Week 48)
研究者
研究点 (150)
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