EUCTR2013-002349-12-IT进行中（未招募）1 期
Switching HIV-positive Women With Undetectable Viremia on Tenofovir/Emtricitabine plus Boosted Atazanavir to RALtegravir (400 mg twice-daily) plus Boosted ATazanavir (300/100 mg once-daily): A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density” - RALBAT Study
nit of Infectious Diseases, Department of Medical Scieces, University of Torino c/o ASLTO2, Amedeo di Savoia Hospital0 个研究点目标入组 66 人开始时间: 2013年6月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- •Adult HIV-positive female patients;
- •osteopenia (t-score from -1 to -2.5)
- •On antiretroviral treatment with tenofovir/emtricitabine and atazanavir/ritonavir (300/100 mg) for at least six months;
- •Plasma HIV RNA below 50 copies/ml since six months;
- •Premenopausal women: female patients at any phase of the reproductive period with regular menstrual cycles and normal FSH (< 25 ng/mL) That would probably esclude patients with ovarian or endocrinological dysfunctions. Pre and postmenopausal should be therefore well-characterized.
- •Women in menopausal period (the menopause was defined as 12 months of amenorrhoea without any pathological or physiological cause and using the endocrinological definition of ovary insufficiency (LH>25ng/mL, FSH>25ng/mL and E2<30ng/mL).
- •Each premenopausal sexually active subject of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 3 months after stopping the medication.
- •Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).
- •Postmenopausal women are not required to use contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
- •Documented resistance to Raltegravir or/and Atazanavir.
- •Patient with significant hypersensitivity or other contraindication to any of the components of the study drugs.
- •Patient has a current (active) diagnosis of acute hepatitis due to any cause
- •Patient with coinfection HIV/HBV
- •Liver cirrhosis
- •Osteoporosis (t-score less than 2.5).
- •Secondary endocrinological cause of low BMD
- •Chronic steroid intake;
- •Chronic kidney disease (estimated glomerular filtration rate below 60 ml/min*24h);
- •Concomitant use of bisphosphonate.
研究者
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