Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Patients' satisfaction with their treatment: HIVTSQs
研究概览
简要总结
With this study the investigators propose to evaluate the satisfaction of the patients receiving antiretroviral treatment for HIV infection with standard everyday scheme, compared to patients receiving the same treatment with short-cycles of 4 days a week.
详细描述
The aim of this study is to evaluate the impact of SCT on the quality of life of HIV infected adults by administering HIV Treatment Satisfaction Questionnaires (HIV-TSQs) to patients receiving SCT for at least 48 weeks and by comparing their answers to those of patients receiving standard 7-days-a-week ART with comparable therapeutic regimens.
This is an interventional study performed at the HIV outpatients clinics of the Infectious and Tropical Diseases department in Azienda Ospedaliera Universitaria Integrata of Verona (Italy).
During standard visits and after collecting their informed consent, the investigators will administer HIV-TSQs to 30 patients receiving 4-days-a-week of rilpivirine-containing regimens (either rilpivrine/emtricitabine/tenofovir alafenamide or rilpivirine + lamivudine/abacavir) and to 30 patients receiving the same regimens but 7-days-a-week.
For the first group, the investigators will consider patients who have switched to a SCT at least 48 weeks before administration of the questionnaire, and data on their viro-immunological status (HIV-RNA, CD4+ cells count and CD4+/CD8+ ratio) after the switch to SCT will be retrospectively collected as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 chronic infection;
- •therapy with three-drugs and standard dosage ART containing rilpivirine: either rilpivirine/emtricitabine/tenofovir alafenamide (Odefsey) or rilpivirine/lamivudine/abacavir;
- •virological suppression (VL<50 copies/ml) for at least 12 months before switching to SCT. One viral blip with VL<200 copies/ml, followed by a second deterrmination after 30 days <20 copies/ml is admitted;
- •CD4+ cells count >200/mmc;
- •no evidence or history of viral resistances against NNRTIs, tenofovir, emtricitabine, abacavir and lamivudine; no history of previous failures with their ART regimens;
- •ability to provide written informed consent.
排除标准
- •evidence or history of viral resistances against NNRTIs, tenofovir, emtricitabine, abacavir and lamivudine; history of previous failures with their ART regimen;
- •diagnosis of any opportunistic infection in the 2 weeks before enrollment;
- •for women, ongoing pregnancy and lactation;
- •history of HBV infection (positive anti-HBc antibodies, with negative anti-HBs antibodies);
- •therapy with experimental drugs/chemotherapy/radiotherapy in the 12 weeks before enrolment;
- •current abuse of drugs or alcohol.
结局指标
主要结局
Patients' satisfaction with their treatment: HIVTSQs
时间窗: immediately after outpatient visit
The patients satisfaction will be assessed using HIVTSQs
次要结局
- Virological suppression in the SCT group(48 weeks before enrollment)
- CD4+ cells count and CD4+/CD8+ ratio in the SCT group(48 weeks before enrollment)