Option B+: ART Safety and Durability During First and Subsequent Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,011
- 试验地点
- 1
- 主要终点
- Proportion of participants with failure on Option B+ first-line treatment
研究概览
简要总结
To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.
详细描述
Option B+ is an innovative strategy pioneered within Malawi that provides universal lifelong ART (tenofovir/lamivudine/efavirenz: TDF/3TC/EFV) for pregnant and breastfeeding women to promote maternal health and prevent HIV transmission to infants. The safety of a TDF/3TC/EFV based regimen used during pregnancy has not been systematically evaluated.
Objective 1: To characterize the long term safety, drug resistance patterns and clinical outcomes among women and their infants enrolled in the Malawi Option B+ program using TDF/3TC/EFV.
- Hypothesis 1: Over 3+ years of anticipated treatment follow-up, TDF/3TC/EFV will be associated with a toxicity rate requiring ART discontinuation of <3% and >90% virologic suppression at 36 months.
- Hypothesis 2: Women with baseline CD4 counts ≤ 350 cells/mm3 will experience greater rates of clinical events, treatment failure and ART toxicity compared to those with CD4 > 350 cells/mm3.
Objective 2: To critically evaluate women with subsequent pregnancies after initial engagement in the Option B+ Program.
Objective 2a: To determine the prevalence of treatment failure among pregnant women presenting to ANC on first-line therapy and evaluate the safety of ATZ/r based therapy among those women requiring second-line therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age ≥16 (includes adults and emancipated minors)
- •HIV positive by 2 rapid tests approved by the Malawi Ministry of Health
- •Willingness to provide informed consent
排除标准
- •Female <16 years
- •HIV negative
- •Incapable of providing informed consent
结局指标
主要结局
Proportion of participants with failure on Option B+ first-line treatment
时间窗: Up to 36 months
Proportion of women who fail first-line treatment as indicated by one or more of the following criteria: WHO Stage 3 or 4 events (as defined by Appendix 60 of the Adult AIDS Clinical Trials Group (AACTG)), or DAIDS grade 3 or 4 toxicity (lab serum markers), or proportion with treatment discontinuation (or death), or proportion with virologic failure (as measured by HIV RNA levels)
次要结局
- HIV RNA level measurement(baseline, months 3, 6, 12, 24, 36)
- Infant neuro-development assessment: Bayley score(Age 3 weeks, months 3, 6, 12, 18, 24, 30, 36)
- HIV antibody testing- infant(age 1 year)
- Pharmacokinetic: progesterone level in women using contraceptive implant(months 3, 6, 12, 24)
- Micronutrient assessment(Baseline, months 6, 12, 24, 36)
- PHQ-9 evaluation(baseline, months 6, 12, 18, 24, 30, 36)
- Family planning use and proportion of women with subsequent pregnancy by 36 months(Up to 36 months)
- Maternal CD4 count(baseline, months 12, 24, 36 post-ART initiation)
- Laboratory serum markers(baseline, months 3, 6, 9, 12, 18, 24, 30, 36)
- Pregnancy outcome assessment(At time of pregnancy completion (birth, termination))
- ART Adherence: pill-count(months 3, 6, 9, 12, 18, 24, 30, 36)