A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Percentage of Participants With at Least One Clinical Adverse Experience
研究概览
简要总结
This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1).
As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use
of raltegravir in the pediatric HIV-infected population in Russia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV positive
- •Weight of at least 7 kg
- •HIV RNA ≥1000 copies/mL within 45 days before study treatment
- •Participants of reproductive potential and sexually active agree to remain
- •abstinent or use (or have their partner use) an acceptable method of birth control throughout the study.
排除标准
- •Females pregnant or breast-feeding, or expecting to conceive or donate eggs
- •during the study; males planning to impregnate or provide sperm donation
- •during the study
- •Use of any non-antiretroviral (ART) investigational agents within one month before study treatment
- •Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and/or C
- •Prior or current use of raltegravir
- •Use of another experimental HIV-integrase inhibitor
- •History or current evidence of any condition, therapy, laboratory
- •abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study
- •Requires or is anticipated to require any prohibited medications
- •Use of immunosuppressive therapy within 30 days before beginning
- •raltegravir study treatment; short courses of corticosteroids are permitted.
- •History of malignancy
- •Current treatment for active tuberculosis infection
- •Use of recreational or illicit drugs or a recent history (within the
- •last year) of drug or alcohol abuse or dependence
研究组 & 干预措施
Raltegravir Film-coated Tablet
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
干预措施: Raltegravir Film-coated Tablet (Drug)
Raltegravir Film-coated Tablet
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
干预措施: Other Anti-Retroviral Therapy (Drug)
Raltegravir Chewable Tablet
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
干预措施: Raltegravir Chewable Tablet (Drug)
Raltegravir Chewable Tablet
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
干预措施: Other Anti-Retroviral Therapy (Drug)
结局指标
主要结局
Percentage of Participants With at Least One Clinical Adverse Experience
时间窗: Up to Week 26
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
时间窗: Up to Week 24
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Percentage of Participants With at Least One Laboratory Adverse Experience
时间窗: Up to Week 26
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
时间窗: Up to Week 24
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
次要结局
- Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL(Week 24)
- Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count(Baseline and Week 24)
- Change From Baseline in CD4 Cell Percentage(Baseline and Week 24)
- Percentage of Participants Achieving HIV RNA <40 Copies/mL(Week 24)
- Percentage of Participants Achieving HIV RNA <200 Copies/mL(Week 24)