EUCTR2017-000050-18-Outside-EU/EEA进行中（未招募）1 期
A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combinationwith Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Childrenand Adolescents - Study of Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient is at least 2 years and <18 years of age, on the day the informed consent is signed; both genders are eligible.
- •2. Patient is at least 7 kg in weight on the day the informed consent is signed.
- •3. Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV RNA from documented medical history.
- •4. Patient has a screening HIV RNA = 1000 copies/mL (completed by the central laboratory) within 45 days prior to the treatment phase of this study.
- •5. Patient has the following screening laboratory values within 45 days prior to the treatment phase of this study.
- •6.1 Alkaline phosphatase = 5.0 x upper limit of normal.
- •6.2 AST (SGOT) and ALT (SGPT) = 5.0 x upper limit of normal. Patients with chronic Hepatitis B and/or C co-infection may be enrolled provided the patients are stable and meet all eligibility criteria.
- •6. Parent and patient (when applicable per local law) are able and willing to provide signed informed consent and understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. Assent will be obtained from minors according to institutional practices.
- •7. Parent and patient (when applicable) are able to read, understand and complete questionnaires and diaries.
- •8. Patient who is of reproductive potential and sexually active agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Female patient is pregnant or breast-feeding, or expecting to conceive or donate eggs
- •during the study. Male patient is planning to impregnate or provide sperm donation
- •during the study.
- •2. Patient has used any non-ART investigational agents within one month prior to
- •treatment in this study.
- •3. Patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic
- •hepatitis other than stable chronic Hepatitis B and/or C.
- •4. Patient has any prior or current use of raltegravir.
- •5. Patient has used another experimental HIV-integrase inhibitor.
- •6. Patient has a history or current evidence of any condition, therapy, laboratory
- •abnormality or other circumstance that might confound the results of the study, or
- •interfere with the patient’s participation for the full duration of the study, such that it
- •is not in the best interest of the patient to participate.
- •7. Parent and patient are unlikely to adhere to the study procedures, keep appointments,
- •or are planning to relocate during the study.
- •8. Patient requires or is anticipated to require any of the prohibited medications noted in
- •section 3.2.1 of this protocol.
- •9. Patient has used immunosuppressive therapy within 30 days prior to beginning
- •raltegravir study treatment. Short courses of corticosteroids (e.g. prednisone or
- •equivalent up to 2 mg/kg/day for two weeks) are permitted.
- •10. Patient has a history of malignancy.
- •11. Patient is receiving treatment for active tuberculosis (TB) infection or disease.
- •12. Patient is a user of recreational or illicit drugs or
研究者
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