Clinical Trials Unit, Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.
Statistical and Data Analysis Center, Harvard University T. H. Chan School of Public Health, Boston, MA.
J Acquir Immune Defic Syndr. 2023 Dec 15;94(5):461-467. doi: 10.1097/QAI.0000000000003299.
Women are under-represented in clinical trials and must often commit to using contraception to enroll. We sought to determine the incidence and predictors of pregnancy in women participating in HIV treatment trials.
Individual participant data meta-analysis.
We included data from multicountry HIV treatment trials conducted during the period 2005-2019 by the AIDS Clinical Trials Group that included females with HIV who were of reproductive potential, did not intend to become pregnant, and agreed to use effective contraception during study treatment. We extracted data from all female participants of age 18-55 years, including occurrence and dates of pregnancy on-study; however, only a few incident pregnancy predictor variables were available for analysis.
One thousand six hundred twenty-six women from 4 trials were included. Over a median of 28 months (6461 person-years) of follow-up, 143 (9%) women became pregnant, for an overall incidence of 2.2 pregnancies/100 person-years (range 0.5-3/100 person-years, by study). In multivariable analysis including baseline age, type of regimen, and country as predictor variables, younger age remained the strongest predictor of incident pregnancy ( P < 0.0001 adjusted for country and antiretroviral treatment regimen). CD4 and HIV-1 RNA were not associated with pregnancy incidence.
Pregnancy incidence was 2.2/100 person-years in female participants of HIV treatment trials. Rather than leading to exclusion of young women from trials, this finding should prompt appropriate adaptations in study design and analysis for earlier generation of pregnancy safety information for drugs.
女性在临床试验中的代表性不足，并且经常需要承诺使用避孕措施才能入组。我们旨在确定参与 HIV 治疗试验的女性怀孕的发生率和预测因素。
个体参与者数据的荟萃分析。
我们纳入了 2005 年至 2019 年期间由艾滋病临床试验组进行的多国家 HIV 治疗试验的数据，这些试验包括具有生育潜力的 HIV 女性感染者，她们不打算怀孕，并同意在研究治疗期间使用有效的避孕措施。我们从所有年龄在 18 至 55 岁的女性参与者中提取数据，包括研究期间怀孕的发生和日期；然而，仅有少数偶发妊娠预测变量可用于分析。
来自 4 项试验的 1626 名女性被纳入。在中位数为 28 个月（6461 人年）的随访期间，143 名（9%）女性怀孕，总发生率为每 100 人年 2.2 例妊娠（范围为 0.5-3/100 人年，按研究划分）。在包括基线年龄、方案类型和国家作为预测变量的多变量分析中，年龄仍然是偶发妊娠的最强预测因素（经国家和抗逆转录病毒治疗方案调整后，P<0.0001）。CD4 和 HIV-1 RNA 与妊娠发生率无关。
在 HIV 治疗试验的女性参与者中，妊娠发生率为每 100 人年 2.2 例。这一发现不应导致年轻女性被排除在试验之外，而应促使在研究设计和分析中进行适当的调整，以便更早地获得药物妊娠安全性信息。
