NCT01597180撤回不适用
Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in cervicovaginal fluide milieu
研究概览
简要总结
The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.
The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 20-40 years of age with regular monthly menses
- •If over age 35 then must not use tobacco
- •Negative pregnancy test
- •No known allergy to raltegravir
- •No known history of phenylketonuria
- •Undetectable HIV viral load
- •No active liver disease as determined by medical history and normal AST and ALT
- •No history of hepatic adenomas, carcinomas or benign liver tumors
- •Ho history of thrombophlebitis of thromboembolic disease
- •No history of deep vein thrombosis
- •No history of cerebral vascular or coronary artery disease
- •No known or suspected carcinoma of the breast
- •No undiagnosed abnormal genital bleeding
- •Not taking concomitant CYP 450 inducing medications such as anti-seizure medications
- •No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening
- •No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- •Has used raltegravir prior to screening
- •Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)
- •Must not have had an abnormal pap test defined without resolution in the last 18 months.
排除标准
- 未提供
结局指标
主要结局
Change in cervicovaginal fluide milieu
次要结局
未报告次要终点
研究者
Gretchen Stuart, MD
Associate Professor, Department of Obstetrics and Gynecology
University of North Carolina, Chapel Hill
研究点 (1)
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