Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 5
- 主要终点
- Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at Week 24
研究概览
简要总结
The primary purpose of the study is to evaluate the efficacy of rilpivirine (RPV)-based regimen in human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive participants, as determined by the percentage of virologic responders defined as having HIV-1 ribonucleic acid (RNA) less than 400 copies/ milliliter (mL) at Week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Must have documented human immunodeficiency virus type 1 (HIV-1) infection
- •Must be antiretroviral (ARV) treatment-naïve
- •Have plasma HIV-1 ribonucleic acid (RNA) less than (<) 100,000 copies/milliliter (mL) at screening visit
- •Have cluster of CD4+ T-cell count (greater than) >200/ cubic millimeter (mm^3) at screening visit
- •Women of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening; and a negative urine (or serum, if required by local regulations) pregnancy test before the first dose of study
排除标准
- •History of any primary nucleo(t)side reverse transcriptase inhibitor (N[t]RTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations (if testing performed locally, and results are available), as defined by the current International AIDS (acquired immunodeficiency syndrome) Society-United States (USA) (International Antiviral Society-USA) 2017 guidelines
- •Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency)
- •Diagnosed with acute viral hepatitis at screening or before baseline
- •Infected with Mycobacterium tuberculosis which is likely to require rifampicin-based treatment during the study
- •Has a Grade 3 or 4 laboratory abnormality as defined by the Division of AIDS (DAIDS) for Grading the Severity of Adult and Pediatric Adverse Events criteria with the following exceptions unless clinical assessment foresees an immediate health risk to the participant: (a) Preexisting diabetes or with asymptomatic glucose Grade 3 or 4 elevations (b) Asymptomatic triglyceride or cholesterol elevations of Grade 3 or 4
研究组 & 干预措施
Treatment: Rilpivirine+Combination Therapy (TDF/3TC)
The participants will receive antiretroviral treatment of rilpivirine 25 milligram (mg) tablet orally once daily from Day 1 for 48 weeks with a meal to improve absorption. The participants will also receive background combination therapy of 1 tablet orally once daily containing 300 mg tenofovir disoproxil fumarate (TDF) and 300 mg lamivudine (3TC).
干预措施: Rilpivirine 25 mg (Drug)
Treatment: Rilpivirine+Combination Therapy (TDF/3TC)
The participants will receive antiretroviral treatment of rilpivirine 25 milligram (mg) tablet orally once daily from Day 1 for 48 weeks with a meal to improve absorption. The participants will also receive background combination therapy of 1 tablet orally once daily containing 300 mg tenofovir disoproxil fumarate (TDF) and 300 mg lamivudine (3TC).
干预措施: Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC) (Drug)
结局指标
主要结局
Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at Week 24
时间窗: Week 24
Virologic responders are defined as participants having viral load (plasma Human Immunodeficiency Virus-Type 1 Ribonucleic Acid \[HIV-1 RNA\] levels) less than (\<) 400 copies/milliliter (mL) at Week 24 (Food and Drug Administration \[FDA\]-defined snapshot analysis).
次要结局
- Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at Week 48(Week 48)
- Absolute Value in Cluster of Differentiation 4 Positive (CD4+) T-Cell Count at Weeks 24 and 48(At Weeks 24 and 48)
- Number of Participant with Clinically Significant Change from Baseline in Laboratory Parameters(Baseline up to Week 48)
- Percentage of Participants with Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Participants Experiencing Premature Discontinuation due to AEs Through Week 48(Through Week 48)
- Percentage of Participants who are Virologic Responders (HIV-1 RNA <50 Copies/mL) at Week 24(Week 24)
- Change from Baseline in CD4+ T Cell Count at Weeks 24 and 48(Baseline, Weeks 24 and 48)
- Percentage of Participant with Treatment Adherence (95%) Based on Tablet Count up to Weeks 24 and 48(Up to Weeks 24 and 48)
- Percentage of Participants with Laboratory Abnormalities(Up to Week 48)
- Emergence of Viral Resistance Through Weeks 24 and 48(Through Weeks 24 and 48)