EUCTR2011-005270-35-IT进行中（未招募）不适用
HIV-infected pregnant women treated with HAART: registry of pharmacokinetic parameters of new and commonly used antiretrovirals
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点开始时间: 2012年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Pregnant women (> 18 years) receiving HAART or who start HAART (standard dose);
- •-Signature of appropriate informed consent;
- •-Administration of antiretroviral drugs as indicated in the data sheet for each product.
- •- Subject-able to adhere to the recommended diet.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any disease-AIDS-defining active at enrollment.
- •Presence of a new diagnosis of opportunistic infection or HIV-relata of any medical condition that requires immediate treatment at enrollment.
- •-Presence of anemia grade III / IV (Hb <4.6 mmol / L or <7.4 g / dL)
- •Presence of relevant conditions, current or past, which could interfere with the absorption, distribution, metabolism and elimination of drugs.
- •Any active-obstetric complication requiring interruption of HAART, or the administration of therapies not covered in the study.
- •Any abnormal fetal-known.
- •Clinically relevant disease-active, which in the opinion of the investigator, could compromise the safety of the patient or the result of the study.
- •-Any condition that, in the opinion of the investigator, may compromise the safety of the patient and the membership or protocol.
- •-Any contraindication to the use of antiretroviral drugs, as therapeutic indications.
- •-Creatinine clearance <50 mL / min at screening or evidence of renal involute years;
- •-Use of psychoactive substances that may in any way interfere with the patient's adherence to the prescribed regimen;
- •-Persons who, in the opinion of the investigator, does not ensure adequate adherence to the study;
- •-Patients who are receiving or have received antineoplastic or immunomodulatory activities over the past 12 months;
- •- Participation in other clinical trials with experimental drugs or medication during the 30 days prior to entry in the protocol;
- •- Inability to sign informed consent.
研究者
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