Effects of Protease Inhibitor Use on Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics in HIV-positive Women
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Levonorgestrel Area Under the Curve
研究概览
简要总结
The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. In addition, the prevalence of ovulation will be measured in each group. Participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic study. The investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be unchanged.
This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. In addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. As a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV positive
- •Age 18-45
- •Using any of the following medication regimens: no ARV medication, entry inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), integrase inhibitors, and CCR5 agonists. Acceptable NRTI combinations include zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF)
- •Ovulatory (mid-luteal progesterone >3ng/dL)
- •Not planning to conceive during the study period
- •Willing to abstain from grapefruit products
- •If taking ritonavir, willing to use alternate non-hormonal contraception
- •BMI < or = 40
- •Able to consent in English or Spanish
- •No change in medication regimen for at least 21 days prior to study entry and no planned change during the study period
- •CD4 > or =200, and/or not considered profoundly immuncompromised by primary HIV provider
排除标准
- •Using on the combination of ZDV at d4T
- •Platelets <50,000
- •AST or ALT > twice upper limit of normal
- •Bilirubin > twice upper limit of normal
- •Use of other CYP3A4 inducing or inhibiting medications
- •Pregnant or breastfeeding in last 30 days
- •Use of DepoProvera in last 180 days
- •Use of any other hormonal contraception in last 30 days
- •Undiagnosed vaginal bleeding or invasive cancer of the reproductive tract
- •>50% change in tobacco use in the last month
- •Initiation or titration of methadone therapy in the last month
- •Uncontrolled thyroid disease
- •Contraindication to estrogen use
- •Inability to comply with study protocol
研究组 & 干预措施
Ritonavir
Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.
干预措施: Levonorgestrel and Ethinyl Estradiol (Drug)
Control
Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.
干预措施: Levonorgestrel and Ethinyl Estradiol (Drug)
结局指标
主要结局
Levonorgestrel Area Under the Curve
时间窗: 24 days
Levonorgestrel AUC from 0 to 72 hours
次要结局
- Ethinyl Estradiol Area Under the Curve(24 days)
- Serum Progesterone Level >3ng/dL Reflecting Ovulation(21 days)
研究者
Nicole Bender
Assistant Professor
University of Southern California