A Randomized Comparative Clinical Trial of ZDV + 3TC + ABC (Trizivir) vs Monotherapy With Lopinavir/R (Kaletra) in Patients With Viral Suppression on Previous Treatment With ZDV + 3TC + ABC (Trizivir) for Preventing Lipoatrophy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Limb Fat changes measured by DEXA
研究概览
简要总结
The aim of this study is to measure the prevention of lipoatrophy in patients treated with Lopinavir/R in monotherapy versus ZDV + 3TC + ABC
详细描述
In recent years mayor progress has been made in therapeutic approaches with the introduction of HAART, which has meant a huge fall in morbidity-mortality in Western countries.
However, despite having a variety of potent HAART combinations, some patients do not obtain adequate suppression. The causes of virological failure are complex, and one of the most significant factors is the incomplete compliance with the prescribed dosage of highly-active antiretroviral therapy (HAART). The development of fixed dose combination products is most commonly used to help simplify the dosages and improve treatment compliance.
One of the main problems associated with the treatment of HIV infection is the change in body structure, generally grouped under the term of lipodystrophy. These usually include fat accumulation in the stomach, or abdominal girth, and, even worse, atrophy in the face, arms, and legs. It is usually associated with metabolic disorders, with increased levels of triglycerides, cholesterol and/or insulin resistance.
The incidence of lipodystrophy increases progressively over time in patients starting treatment with antiretroviral agents. It is estimated that, after 2 years of treatment, 20%-30% of patients experience moderate or severe lipodystrophy.
Trizivir® is a combination of three antiretroviral agents: Abacavir, Lamivudine and Zidovudine in a tablet. All of them belong to the group of nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients infected with HIV 1 documented by positive HIV 1 antibody test and/or positive PCR test confirmed for HIV 1 RNA.
- •Patients on treatment with Trizivir with an undetectable viral burden defined as < 50 copies/ml in the past 6 months.
- •Men or women aged ≥ 18 years.
- •CD4 cell count ≥ 200 cells/μl.
- •For women of child bearing age, a negative urine pregnancy test at the screening visit.
- •Patients giving their written informed consent before completing any study specific screening procedure.
排除标准
- •Patients with previously failed therapy with protease inhibitors (PI) or those receiving sub optimum therapy with nucleoside analogue reverse transcriptase inhibitors (NRTI) for the study disease.
- •Presence of lipoatrophy defined by the investigator (any grade) or by the patient (in this case, at least two sites of mild degree or one of at least moderate degree).
- •Known history of drug addiction or chronic use of alcohol that, in the investigator's opinion, contraindicates participation in the study.
- •Pregnant or nursing women or women of child bearing age not using an adequate contraceptive method according to the investigator's criterion.
- •Current active opportunistic infection or documented infection in the 4 weeks prior to screening.
- •Renal disease with creatinine clearance < 50 ml/min.
- •Concomitant use of nephrotoxic or immunosuppressive agents.
- •Patient currently treated with systemic corticosteroids, interleukine 2, or chemotherapy.
- •Patients treated with other investigational agents.
- •Patients with acute hepatitis.
- •Any disease that, at the criterion in the investigator, contraindicates the patient's participation in the study.
研究组 & 干预措施
2
Switching to LPV/r monotherapy
干预措施: AZT+3TC+ABV (Trizivir) (Drug)
2
Switching to LPV/r monotherapy
干预措施: Switching to LPV/r monotherapy (Kaletra) (Drug)
结局指标
主要结局
Limb Fat changes measured by DEXA
时间窗: 48 weeks
次要结局
- 20 % loss peripheral fat measured by DEXA(96 weeks)
- Perception of change on body fat by physician and patient.(96 weeks)
- Lipohypertrophy(96 weeks)