Comparing Type and Prevalence of HIV Drug Resistance in Treatment Experienced and naïve HIV-infected Adults in Uganda and Switzerland
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,750
- 试验地点
- 1
- 主要终点
- HIV drug resistance in treatment-naive patients
研究概览
简要总结
The investigators aim to assess type and frequency of HIV drug resistance in adults presenting to the Infectious Diseases Institute (IDI) in Kampala, Uganda, and compare this data to patients from the Swiss HIV Cohort Study (SHCS). This study is a single-site, cross-sectional study. The Investigators' goal is to perform viral load measurements in 2750 HIV-infected patients who have been on ART for 6 months or more. Presuming a detectable viral load in 10%, resistance testing would then be performed in 250 patients on ART. All adult patients attending will be screened for enrollment. Furthermore, the investigators' goal is to perform resistance testing in 250 ART naive patients in order to detect transmitted resistance mutations. Investigators will therefore consecutively screen and enroll 250 ART naive patients who attend the clinic during the study period. For each participant, a case report form (CRF) form will be completed which includes social, as well as medical information. Investigators will ask each participant for permission to store plasma in case resistance testing must be repeated, and serum, in case of future research questions.
详细描述
Background & Rational Uganda and Switzerland are two examples of regions in the world that have experienced the era of antiretroviral treatment (ART) in substantially different ways. While European patients had access to ART from the beginning of drug development, ART was made accessible to patients from sub-Saharan Africa many years later. HIV-infected patients in resource-limited settings were not subjected to the early days of treatment, were mono therapy was tried or combinations of drugs that are off the market nowadays. Furthermore, in contrast to European patients, patients from resource-limited settings were constantly confronted with economic constraints leading to stock-outs for instance. Cultural aspects, such as stigma and fear of disclosure, differ as well, and are well known to influence individual adherence and treatment outcome substantially.
Today similar first-line treatment choices are made by Ugandan and Swiss physicians, but monitoring strategies still differ. As in other countries of sub-Saharan Africa, treatment of HIV-infected patients is monitored immunologically and clinically, while viral load measurement is reserved for selected patients. In accordance with WHO recommendations treatment failure is therefore determined clinically (new or recurrent WHO stage III or IV condition) and/or by the decline of a patient's CD4 cell count to or below baseline, which usually occurs late during insufficient treatment. Viral rebound and emergence of resistance may thereby arise. Moreover, misclassification of treatment failure (e.g. patients with immunological failure in the absence of virological failure or complete non-adherence to treatment) may result in premature switching to more costly second-line treatment options.
The currently available information on transmitted drug resistance (TDR) in Ugandan adults shows lower rates compared to patients from European countries, including Switzerland. Yet, available studies were conducted with small patient numbers. Newer data from Uganda, especially under new WHO treatment recommendations, is not available yet.
To the best of investigators' knowledge, so far no study has directly compared HIV drug resistance data from a resource-limited country to a resource-rich country. Little is known about the effects of historically, culturally and economically different ART experiences on resistance. With the 2013 WHO guidelines, ART roll-out will be enhanced globally and the continued success of these large-scale treatment programs will depend on the prevention of further emergence of drug resistance.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study.
- •Participants who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
- •Age ≥ 18 years
- •ART naïve OR on stable ART regimen ≥ 6 months (first- or second-line)
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
HIV drug resistance in treatment-naive patients
时间窗: up to 12hrs
Type and frequency of transmitted HIV drug resistance mutations detected in treatment naive patients and comparison to naive patients in the Swiss HIV Cohort Study (SHCS) • Identification of risk factors associated with the occurrence of transmitted HIV drug resistance mutations in treatment-naive patients
HIV drug resistance in treatment-experienced patients
时间窗: up to 12hrs
• Type and frequency of HIV drug resistance mutations detected in patients on ART with virological failure and comparison to patients on treatment the Swiss HIV Cohort Study (SHCS) Identification of risk factors associated with the detection of HIV drug resistance mutations in treatment-experienced patients
次要结局
- Viroligical failure(up to 12hrs)
研究者
Infectious Diseases Institute
Principal Investigator
Makerere University
