Mecahnisms of Lipodystrophy in HIV-Infected Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Effect of Drug Regimens on Serum Triglycerides.
研究概览
简要总结
The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.
The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.
详细描述
A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Positive
- •No previous antiviral therapy
- •18 to 70 years of age
排除标准
- •Patients with opportunistic infections or AIDS.
- •Active intravenous drug users.
- •Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace.
- •Patients with diabetes mellitus.
- •Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week).
- •Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).
- •Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL.
- •Anemia (hematocrit <32%).
- •Abnormal thyroid function tests.
- •Weight loss >10% from baseline in the past year.
- •Recent (within the past year), history of suicide attempt.
研究组 & 干预措施
Nelfinavir (Viracept)
干预措施: Nelfinavir (Drug)
Efavirenz (Sustiva)
干预措施: Efavirenz (Drug)
结局指标
主要结局
Effect of Drug Regimens on Serum Triglycerides.
时间窗: 12 and 24 months
次要结局
未报告次要终点