Prevalence of NRTI, NNRTI, PI and INSTI Primary Resistance-Associated Mutations of Adult Naïve HIV-1 Seropositive Patients in Colombia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 527
- 试验地点
- 1
- 主要终点
- Prevalence of primary HIV drug associated resistance in Colombia
研究概览
简要总结
The investigators' main objective is to determine the prevalence of pre-treatment of resistance-associated mutations (RAMs) in a naïve and recently diagnosed HIV infection in 18 centers from 12 cities in Colombia. This evaluation will include the genotyping of all three enzymes, reverse transcriptase, protease, and integrase. This type of complete primary resistance profile has not yet been reported in Colombia and there is only scanty data regarding resistance-associated mutations to NRTIs, NNRTIs, and PIs in the country
详细描述
The number of patients and sample size:
The proportion formula for finite populations was used to determine the sample size (with appropriate confidence intervals) needed to find the prevalence of RAMs in naive HIV population from Colombia.
As shown below, estimating 20% of loss, the sample size will be 500 study subjects considering a CI 97%.
The sample size is estimated in 501 patients, considering 1% or less of the probability of finding pre-treatment resistance-associated mutations affecting integrase inhibitors, a CI of 97%, and 20% of blood samples loss or not processable.
Sample selection:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive HIV-positive individuals aged 18 years or older.
- •Consent to participate in the research.
排除标准
- •Patients with any type of antiretroviral exposure
结局指标
主要结局
Prevalence of primary HIV drug associated resistance in Colombia
时间窗: November 2019 - December 2020
Prevalence estimated by nationwide sampling of adults HIV positive individuals
次要结局
- Outcomes by demographic characteristics(November 2019 - September 2022)
- Resistance to integrase(November 2019 - September 2022)
- Correlate of HIV-1 sequencing by Sanger vs Next-Generation Sequencing techniques(November 2019 - September 2022)