PACTR202108805211718招募中未知
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
nivesity of Washington0 个研究点目标入组 700 人开始时间: 2021年8月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 700
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
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion Criteria (PK study):
- •Female sex,
- •HIV-positive (for PK groups #1-4 and hybrid trial) or HIV-uninfected (for PK group #5 only),
- •Age 15-24 years at the time of enrollment,
- •Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study screening,
- •Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,
- •Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,
- •Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period
- •Able to consent or assent (with parental consent) for study participation in English or Kiswahili
- •Inclusion Criteria (Hybrid trial):
- •Female sex,
- •HIV-positive,
- •Age 15-24 years at the time of enrollment,
- •Documented or confirmed viral suppression for HIV (defined as <40 copies/mL) within 6 months prior to study screening,
- •Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,
- •Able to consent or assent (with parental consent) for study participation in English or Kiswahili
排除标准
- •Exclusion Criteria (PK study):
- •Already be on ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
- •Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,
- •Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
- •Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,
- •Current or planned concomitant use of other hormonal contraceptives,
- •Be obese (BMI=30),
- •Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded).
- •Serum ALT>5x ULN at the time of screening,
- •Serum creatinine >2.5x ULN at the time of screening.
- •Exclusion Criteria (Hybrid trial):
- •Already be on ART that concurrently contains combinations of nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
- •Currently pregnant or intends to become pregnant or breastfeeding within the next one year,
- •Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,
- •Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,
- •Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded).
- •Serum ALT>5x ULN at the time of screening,
- •Serum creatinine >2.5x ULN at the time of screening.
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