NCT00829114已完成4 期
Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Ovulation as determined by weekly blood progesterone (P) measurement
研究概览
简要总结
Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to provide informed consent
- •Willing to take COCs and follow all study requirements
- •Has regular menstrual cycles every 21-35 days (when not taking hormonal contraception)
- •Last menstrual period (LMP) <35 days before study entry
- •Has body mass index of 18-30
- •Negative urine pregnancy test as enrollment
- •Documented HIV-1 infection
- •On nevirapine-containing ART for at least three months (ART group only)
- •CD4 cell count of greater than or equal to 350 (for non-ARV group only)
- •Currently sexually active and plans to stay sexually active for the next 6 months
排除标准
- •Medical contraindications to COC use
- •Recent pregnancy (within 3 months)
- •Has breastfed in last 3 months
- •Last pregnancy was ectpoic
- •Has been sterilized
- •Has had any of the following conditions since last pregnancy, or since menarche if never pregnant:
- •Pelvic Inflammatory disease Diagnosis of infertility
- •Has had DMPA within 6 months or NET injectable within 3 months of study entry (or has had no menses since last injection regardless of its timing)
- •has taken other hormonal therapies besides COCs (e.g., combined injectables, progestin implants or intrauterine systems, progestin-only contraceptive pills, medroxyprogesterone acetate, hormone replacement therapy) within 30 days of study entry
- •Has an acute infection or other opportunistic diseases requiring therapy within 14 days before enrollment
- •Has active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- •Has taken any prohibited medication within 30 days before study entry
- •Has chronic diarrhea, malabsorption or inability to maintain an adequate oral intake
- •Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation
研究组 & 干预措施
1
Active Comparator
ART/COC group
干预措施: ETHINYL ESTRADIOL AND LEVOGESTREL (Drug)
2
Active Comparator
COC group
干预措施: ETHINYL ESTRADIOL AND LEVOGESTREL (Drug)
结局指标
主要结局
Ovulation as determined by weekly blood progesterone (P) measurement
时间窗: 2 months
次要结局
- Pregnancy as detected by monthly urine pregnancy testing(6 months)
- Adverse events (AE) recording(6 months)
研究者
研究点 (2)
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