PER-024-19尚未招募未知
AN OPEN-LABEL, PHASE II PHARMACOKINETIC STUDY TO EVALUATEDOUBLE-DOSE LEVONORGESTREL EMERGENCY CONTRACEPTION INCOMBINATION WITH EFAVIRENZ-BASED ANTIRETROVIRAL THERAPY ORRIFAMPICIN-CONTAINING ANTI-TUBERCULOSIS THERAPY
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 0 人开始时间: 2020年1月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Postmenarcheal female. 2. The following laboratory values obtained
- •within 30 days prior to study entry: • Absolute neutrophil count (ANC)
- •≥500 cells/mm3 • Platelet count ≥50,000 platelets/mm3 • Hemoglobin
- •≥8.0 g/dL • Aspartate transaminase (AST) <5 x upper limit of normal
- •(ULN) • Alanine aminotransferase (ALT) <5 x ULN • Creatinine ≤1.5 x ULN
- •Total bilirubin ≤2.0 x ULN. 3. Negative serum or urine pregnancy test
- •within 30 days prior to study entry and within 48 hours prior to entry (if
- •screening occurs more than 48 hours prior to entry) The serum or urine
- •pregnancy test must have a sensitivity of at least 25 mIU/mL. 4. Has not
- •had sex that could lead to pregnancy without contraception within 14 days
- •prior to study entry. 5. Contraception requirements: All participants must
- •agree not to participate in a conception process (e.g., active attempt to
- •become pregnant or in vitro fertilization) for the duration of the study.
- •Women of reproductive potential, who are participating in sexual activity
- •that could lead to pregnancy, must agree to use at least one reliable
- •method of contraception while in the study. Acceptable forms of
- •contraceptives include: • Male condom with or without a spermicidal agent
- •Diaphragm or cervical cap with spermicide • Non-hormonal IUD •
- •Bilateral tubal ligation • Male partner vasectomy. 6. Women and girls
- •major iqual to 16 years of age. 7. Ability and willingness of participant or
- •legal guardian/representative to provide informed consent. 8. BMI (kg/m2)
- •available at entry. Note: A maximum of 5 participants with BMI ≥30
- •kg/m2 will be allowed in each arm B-D and a maximum of 3 participants in
- •Arm A. 9. For women living with HIV: HIV-1 infection, documented by any
- •licensed rapid HIV test or HIV enzyme or chemiluminescence
- •immunoassay (E/CIA) test kit at any time prior to study entry and
- •confirmed by a licensed Western blot or a second antibody test by a
- •method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen,
- •plasma HIV-1 RNA viral load. 10. For women living with HIV: Receiving a
- •stable qualifying concomitant ART regimen containing either once-daily
- •DTG 50 mg or EFV 600 mg with no changes in the components of their
- •ART for at least 30 days prior to study entry. 11. For women who are
- •being treated for TB: HIV-negative at screening, documented within the
- •prior 6 months by any licensed rapid HIV test or HIV enzyme or
- •chemiluminescence immunoassay (E/CIA) test kit and confirmed by a
- •licensed Western blot or a second antibody test by a method other than
- •the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV-1
- •RNA viral load. 12. For women who are HIV-negative and being treated for
- •TB: Receiving RIF and INH on a once daily dosing (7 days per week)
- •schedule at study entry, after completion of the intensive phase of TB
- •treatment. Note: Inclusion of ethambutol as part of continuation phase of
- •TB therapy is allowed. 13 . Ability and willingness of participant to be
- •contacted remotely for study visits.
排除标准
- •1. Known allergy/sensitivity or any hypersensitivity to LNG or components
- •of the formulation. 2. Bilateral oophorectomy, hysterectomy, or
- •postmenopausal. Note: Postmenopausal is defined as amenorrhea for at
- •least 12 consecutive months prior to study entry (in the absence of
- •medications known to induce amenorrhea), and have a documented
- •follicle stimulated hormone-release factor (FSH) measurement >40
- •mIU/mL or a result in the testing laboratory’s menopausal range. If an
- •FSH level is not available, 24 consecutive months of amenorrhea prior tostudy entry (in the absence of medications known to induce amenorrhea).
- •Note: Clinical assessment and clinician’s opinion are acceptable. 3.
- •Currently pregnant, within 6 weeks of delivery, or currently breastfeeding
- •an infant under 6 months of age. Note: For recent pregnancy resolution
- •during the first or second trimester, the participant is only eligible when
- •the pregnancy test result is negative. 4. Receipt of LNG within 30 days
- •prior to study entry. 5. Receipt of depo-medroxyprogesterone for 90 days
- •prior to study entry, or norethisterone enanthate (NET-EN) within 60 days
- •prior to study entry, or other hormonal contraceptives within 30 days prior
- •to study entry. 6. Use of any drugs other than RIF and EFV known to: 1)
- •induce CYP3A4 system within 30 days prior to study entry, and 2) inhibit
- •the CYP3A4 system within 7 days prior to study entry. See Appendix IV for
- •prohibited and precautionary medications. 7. Active drug or alcohol use or
- •dependence that, in the opinion of the site investigator, would interfere
- •with adherence to study requirements. 8. Acute or serious illness requiring
- •systemic treatment and/or hospitalization within 14 days prior to study
- •entry. 9. Other medical, psychiatric, or psychological condition that, in the
- •opinion of the site investigator, would interfere with completion of study
- •procedures and or adherence to study drug. 10. For women living with
- •HIV: Currently receiving medications for TB infection. 11. For women living
- •with HIV: Has missed one or more of the prescribed doses of HIV
- •medications within 3 days prior to study entry. Note: The entry visit may
- •be rescheduled within the screening period once the participant has taken
- •all prescribed doses within 3 days prior to study entry. 12. For women who
- •are HIV-negative and being treated for TB: Has missed one or more of the
- •prescribed doses of TB medication within 3 days prior to study entry.
- •Note: The entry visit may be rescheduled within the screening period once
- •the participant has taken all prescribed doses within 3 days prior to study
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