RBR-9nq7qd招募中1 期
Open, randomized study to evaluate the safety and pharmacokinetic parameters comparing antiretroviral formulations fixed-dose tablet and oral solution in pediatric population
niversidade Federal de Minas Gerais0 个研究点开始时间: 2016年4月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 6M 至 13Y（—）
入选标准
- •Weight between 6.5 and 24.9kg;Confirmed HIV infection; documented by positive results from two samples collected at different times prior to entering the study:Sample # 1 can be tested using:Two rapid tests from two different manufacturers antibodies or based on principles and different antigenic determinants (for larger participants 18 months);An essay EIA OR Western blot OR immunofluorescence assay OR chemiluminescence assay (for larger participants 18 months);A PCR HIV DNA;A quantitative PCR HIV DNA (> 5,000 copies / mL);A qualitative PCR HIV DNA;
- •A complete test detection of nucleic acids for the HIV virus;2. Sample # 2 can be tested using:An EIA confirmed OR Western blot OR immunofluorescence assay OR chemiluminescence assay (for larger participants 18 months);
- •A PCR HIV DNA;A quantitative PCR HIV DNA (> 5,000 copies / mL);A qualitative PCR HIV DNA;
- •A complete test detection of nucleic acids for the HIV virus;In use of highly active antiretroviral therapy (HAART); with stable laboratory tests (viral load and CD4 +) or treatment-naïve;Demonstrate availability and willingness to ingest the drugs studied;
- •5. Willingness to stay in the hospital for 12 hours for pharmacokinetic study;Parents or legal guardians must be able; agree and are willing to sign the Instrument of Consent;
- •Female participants; after menarche; must agree to use two forms of contraception from the menarche;Note: female participants with reproductive potential (after menarche) with sexual activity that can result in pregnancy; they must agree to avoid pregnancy in a consistent and appropriate manner with at least two of the following contraceptive methods: condoms; diaphragm or cervical cap with spermicide; IUD; hormonal contraceptives.
排除标准
- •Values outside normal laboratory tests in step 4; according to the DAIDS toxicity table (Annex IV); up to 2 weeks before study entry;Vomiting and diarrhea (greater than grade 2) at least 30 days prior to study entry;Treatment of bacterial; viral or acute severe opportunistic;History of drug toxicity requiring discontinuation of any study drug;Hypersensitivity to drugs under study;medical or surgical problems affecting motility or gastrointestinal absorption (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 clinically significant findings during the medical assessment or physical examination that; in the opinion of the investigator; may interfere with the study;Pregnancy;Failure immune defined as:Incomplete immune response: defined as a failure in subjects with severe immunodeficiency (baseline CD4 percentage <15%) to achieve at least five percentage points increment or children 5 years of age; to increase the absolute value of CD4 . at least 50 cells / mm3 during the first year of treatment;Immune Worsening: defined as the sustained drop of five points in the percentage of CD4 at any age; or fall to values below the absolute number of pretreatment CD4 in children 5 years of age (Brazil; 2009).
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