PACTR202301600757432招募中3 期
Efficacy, Safety and Effectiveness of Injectable Cabotegravir / Rilpivirine in Improving HIV-1 Control in Sub-Saharan Africa : A Pragmatic Phase 3b Open- Label Randomized Controlled Trial.
MRC UVRI LSHTM Uganda Research Unit0 个研究点目标入组 540 人开始时间: 2023年1月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
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
- All
入选标准
- •18 years of age and above
- •HIV-1 infection confirmed in clinic records or by study team.
- •Two consecutive HIV-1 VL <200 copies/mL =3 months apart prior to randomization.
- •On an oral regimen of 2NRTI + DTG as part of first line ART
- •Is identified as a participant with a history of, sub-optimal ART adherence or engagement in care based on one or more of the following criteria:
- •Documented detectable HIV-1 VL (>1000 c/mL) on all-oral ART (EFV/NVP or DTG-based) in the prior 2 years despite being ART-experienced for =3 months.
- •History of being lost to follow-up from care (>4 weeks elapsed since a missed scheduled clinic appointment or refill in the prior 2 years).
- •Failed to link to HIV care despite =3 months elapsed since HIV diagnosis.
- •Females: human chorionic gonadotrophin (HCG) negative and willing to use one highly effective form of contraception if woman of reproductive potential
- •Must sign informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •Willing and able to attend all clinic appointments.
排除标准
- •Not virologically suppressed (VL<200 c/mL) for =3 months at the end of the screening process.
- •Previous use, or intention to use, protease inhibitor-based ART at any time.
- •Evidence of prior HIV-1 resistance test with NNRTI drug resistance mutations (other than K103N) and/or INSTI drug resistance mutations.
- •Unwillingness to receive 2 injections on a 2 monthly basis.
- •Unwilling to use a form of contraception.
- •Pregnant, breastfeeding or planning to become pregnant during the study period.
- •Requires tuberculosis therapy or other drug with clinically relevant drug interaction
- •High risk of seizures, including participants with an unstable or poorly controlled seizure disorder.
- •Has active TB or other mycobacterial disease and requires treatment.
- •Advanced liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or history of cirrhosis.
- •Chronic Hepatitis C with planned or anticipated use of Hep C therapy
- •Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) as follows:
- •Participants positive for HBsAg are excluded
- •Participants negative for HBsAg but positive for HBcAb, with no evidence of HBsAb are excluded NOTE: Participants positive for HBcAb due to prior infection (negative HBsAg status) and with evidence of HBsAb have some immunity to HBV and have low risk of reactivation so are not excluded.
- •Current or anticipated need for chronic anticoagulation therapy.
- •Previous use of oral or injectable CAB or RPV.
- •Any Grade 4 laboratory abnormality at the conclusion of screening process.
- •Creatinine clearance (CrCl) <50 mL/min/1.732 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation.
- •Alanine aminotransferase (ALT) > 3×upper limit of normal (ULN).
- •Has a tattoo or other dermatological condition overlying the gluteus region that could interfere with ISR interpretation
研究者
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