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Набор скоро начнётся NCT07288190

Phase 2b, Open Label, Multisite, Randomized Crossover Study of DPP Versus 2PR

Фаза II С лечением Pregnancy HIV Infections

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: DPP, 2PR, Free Choice.
Кому может быть актуально
Состояния в реестре: Pregnancy, HIV Infections. Базовые параметры: 16 лет — 39 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Eswatini, Uganda, Zimbabwe
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multisite, Open-label, Randomized Crossover Study Comparing Adherence to a Single Daily Dual Prevention Pill (DPP) Versus FTC/TDF and Combined Oral Contraception Separate Pill Dosing (2PR), Given for Pre-exposure Prophylaxis and Pregnancy Prevention in Women

Обзор

To evaluate adherence to a single dual-prevention pill (DPP) compared with a two-pill regimen (2PR) for pre-exposure prophylaxis (PrEP) and pregnancy prevention in women without HIV.

Подробное описание

To evaluate adherence to a single DPP consisting of co-formulated Tenofovir Disoproxil Fumarate and Emtricitabine (FTC/TDF) plus combined ethinyl estradiol/levonorgestrel oral contraceptive (COC), compared with a two-pill regimen (2PR) consisting of daily oral FTC/TDF pill and combined COC pill, for pre-exposure prophylaxis PrEP and pregnancy prevention in women without HIV.

Вмешательства

  • Препарат DPP
    Daily, single, co-formulated, FTC/TDF + combined ethinyl estradiol/levonorgestrel oral contraceptive pill
  • Препарат 2PR
    Daily, two-pill regimen of oral FTC/TDF and ethinyl estradiol/levonorgestrel oral contraceptive pill
  • Препарат Free Choice
    Choice of either DPP or 2PR

Первичные конечные точки

  • PrEP adherence to DPP during randomized crossover period 1 [Срок оценки: Week 12]
  • PrEP adherence to 2PR during randomized crossover period 1 [Срок оценки: Week 12]
  • PrEP adherence to DPP during randomized crossover period 2 [Срок оценки: Week 24]
  • PrEP adherence to 2PR during randomized crossover period 2 [Срок оценки: Week 24]
Вторичные конечные точки (12)
  • PrEP adherence to DPP during Choice period [Срок оценки: Week 48]
  • PrEP adherence to 2PR during Choice period [Срок оценки: Week 48]
  • PrEP adherence to DPP during Choice period [Срок оценки: Week 48]
  • PrEP adherence to 2PR during Choice period [Срок оценки: Week 48]
  • Acceptability of DPP during crossover period [Срок оценки: Week 24]
  • Acceptability of 2PR during crossover period [Срок оценки: Week 24]
  • Acceptability of DPP during Choice period [Срок оценки: Week 48]
  • Acceptability of 2PR during Choice period [Срок оценки: Week 48]
  • Preference for DPP [Срок оценки: Day 0]
  • Preference for DPP [Срок оценки: Week 24]
  • Preference for 2PR [Срок оценки: Day 0]
  • Preference for 2PR [Срок оценки: Week 24]

Критерии участия

Критерии включения

  • Age 16 through 39 years old (inclusive) at Screening.
  • Adults must be able and willing to provide informed consent. Adolescents (16- and 17-year-olds) will be consented according to applicable local guidelines, by obtaining participant assent and where applicable parental or guardian permission.
  • Able and willing to provide adequate locator information.
  • Able and willing to comply with all study procedures.
  • Must be post-menarche and pre-menopausal and could potentially become pregnant.
  • Sexually active, defined as having had penile-vaginal sex within the 3 months before Screening (per self-report)
  • Negative pregnancy test at Screening and Enrollment.
  • Does not intend to become pregnant within the next 12 months.
  • Willing to use COCs for at least 48 weeks as their method of contraception.
  • HIV negative at Screening and Enrollment.
  • Willing to use oral PrEP for at least 48 weeks.
  • Hepatitis B (HBV) surface antigen (HbsAg) negative per blood test at Screening.
  • Hepatitis C (HCV) negative at Screening.
  • Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening.

Критерии исключения

  • Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.
  • Unable to become pregnant e.g., had a tubal ligation or hysterectomy or otherwise lacks a uterus, or is currently using another form of contraception.
  • Medically ineligible for combined hormonal contraception and specifically COCs per World Health Organization (WHO) medical eligibility criteria for contraceptive use or similar local medical eligibility guidelines (e.g., Centers for Disease Control and Prevention eligibility criteria).
  • Medically ineligible for PrEP based on WHO and/or local guidelines.
  • Using or planning to use another pregnancy prevention product other than oral contraception (condoms are permitted) during the next 48 weeks.
  • Using or planning to use another HIV prevention product other than condoms during the next 48 weeks.
  • Any other condition the clinician feels would jeopardize the health and wellbeing of the participant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Eswatini · 1 центр
  • Eswatini Prevention Center CRS — Mbabane
Uganda · 1 центр
  • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS — Kampala
Zimbabwe · 1 центр
  • Spilhaus CRS — Harare

Идентификаторы

NCT: NCT07288190 · HPTN 104 · UM1AI068619

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗