NCT00160849已完成4 期
Study on the Feasibility of Antiretroviral Therapy With a Single Agent - Lopinavir/r - in Patients Treated With HAART and With Viral Load Below 80 Copies/Ml
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- • Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.
研究概览
简要总结
- Objectives Primary
- To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent
- To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells.
Secondary
- To investigate the rate of clinical and laboratorial adverse events in the two treatment groups.
- To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen.
- To describe the adherence to the prescribed regimen in the two treatment groups
- To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups
- To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups.
- Patient population:
The 60 patients were selected by the investigators according to the study's inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each. 3. Study design:
The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded. 4. Regime:
- Group 1 maintenance of the currently used antiretroviral therapy
- Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit).
- Duration:
96 weeks of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •The patients must fulfill all of the following criteria: The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC). And he/she can withdraw the study participation at any moment, if he/she wants to do so.
- •The patient has laboratorial confirmation of an HIV infection through a positive ELISA test for anti-HIV antibodies and an additional test (Western-blot, indirect immunofluorescence or PCR).
- •The patient must be in treatment with at least three antiretroviral drugs, for at least 6 months without changes.
- •The patient should have no history of documented virological failure to previously used antiretroviral therapies.
- •Undetectable viral load (test result < 400 copies/ml) for more than 6 months measured on a sample collected during treatment with the current regimen and at screening (test result < 80 copies).
- •CD4 count > 200 cels/ml at screening
- •Patient agrees not to use concomitant medication that might have unacceptable drug interactions with the study drug.
- •If the patient is a female, she must have a negative pregnancy test and must agree to use at least 14 days before the study drug administration and for the whole study duration and up to 6 months after, a barrier contraceptive method with a proven reliability track record, as judged by the investigator
排除标准
- •Pregnant or lactating female patient. If the patient becomes pregnant during the study, she will be discontinued from the study.
- •Patients with allergic reaction or hypersensitivity to Lopinavir or Ritonavir .
- •A patient with previous history of opportunistic disease ( appendix 1) or CD4 count below 100 cels/mm
- •A patient who presents any HIV viral load test result above 400 copies/mL over the past 6 months.
- •Patient who is receiving or has received systemic chemotherapy during the past 6 months.
- •Laboratory test results Hemoglobin < 8 g/dl Absolute neutrophil count < 750 cels/mL Platelet count < 20,000/mL Bilirubin > 1.5 x UNL or > 6 x UNL if patient is using Indinavir or Atazanavir ALT and AST > 2 x UNL Creatinine > 2 x UNL
- •Patient is taking any drug known to be contraindicated concomitantly with lopinavir/r. Please refer to the product's package insert.
- •According to the investigator's opinion, the patient has little probability of complying with the study protocol or is unsuitable for any other reason.
结局指标
主要结局
• Rate of suppression of viral load to less than 80 copies/ml on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96.
• Average change of CD4 count on weeks 4, 12, 24, 36, 48, 60, 72, 84, 96
• Two-year incidence rate of immunodeficiency related clinical conditions.
次要结局
- • Toxicity rate (clinical and laboratorial adverse events).
研究者
研究点 (4)
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