RBR-5whk7c进行中（未招募）1 期
open, randomized study for safety evaluation and pharmacokinetic parameters comparing dispersible tablets and efavirenz oral solution in pediatric population;
niversidade Federal de Minas Gerais0 个研究点开始时间: 2016年4月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 3Y 至 13Y（—）
入选标准
- •Age greater than or equal to 3 years and less than 13 years old; weight between 7.5 and 35kg, HIV infection confirmed, documented by positive results from two samples collected at different times prior to entering the study, according to the criteria Sample # 1 below can be tested using rapid tests Two different two or based on different principles and antigenic determinants manufacturers antibodies (only for largest survey participants 18 months);
- •An EIA or western blot assay, or immunofluorescence assay OR chemiluminescence assay (only for largest survey participants 18 months); A PCR HIV DNA; A quantitative PCR HIV DNA (> 5,000 copies / mL); Qualitative PCR DNA of HIV; a complete test of nucleic acid detection for the HIV virus; Sample # 2 can be tested using: a confirmed EIA test or Western blot OR immunofluorescence test or chemiluminescence test (only for largest survey respondents 18 months); a PCR HIV DNA; a quantitative PCR HIV DNA (> 5,000 copies / mL); qualitative PCR HIV DNA, complete testing detection of nucleic acids for the HIV virus; patient using of antiretroviral regimen containing EFV and criteria showing virologic suppression, or
- •Patient with antiretroviral treatment early indication that have a genotyping test indicating absence of mutations to confirm resistance to EFV; Demonstrate availability and willingness to ingest the drugs under study; availability to stay in the hospital for 24 hours for pharmacokinetic study, parents or legal guardians must be able, agree and are willing to sign the consent form Clarified; female participants, after menarche and sexual activity that can result in pregnancy will be guided by the principal investigator, or someone delegated team for him, to avoid pregnancy using at least two contraceptive methods, preferably a hormonal method and another barrier method. The study sponsor will bear the costs of contraceptive methods.
排除标准
- •laboratory test values outside the normal range greater than grade 3 according DAIDS Table toxicity (Annex IV), up to 2 weeks prior to study entry or at any time during the study; Vomiting and diarréiadiarreia (
- •greater than grade 2) 30 days prior to study entry; treatment for bacterial, viral or opportunistic severe acute; History toxicity to drugs requiring discontinuation of any study drug; Hypersensitivity to study medications, medical or surgical problems that affect the motility or absorption gastrointestinal (eg, ileus, ulcerative colitis) or liver function, treatment with experimental drugs within 30 days prior to study entry; any acute hepatitis, chemotherapy for cancer; Any disease or findings clinically significant for the medical assessment or physical examination that, in the opinion of the investigator, may interfere with the study, immune failure defined as:
- •incomplete immune response: defined as a failure, in patients with severe immunodeficiency (baseline CD4 percentage
- •greater than 15%), to achieve at least five percentage points of growth, or for children 5 years old, to increase the CD4 absolute value of at least 50 cells / mm3 during the first year of treatment.
- •immune Worsening: defined as the sustained drop of five points on CD4 percentage at any age, or fall to values below the absolute number of CD4 pretreatment in children 5 years old (Brazil, 2009); Pregnancy
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