A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Absolute Change in CD4 Cell Counts
研究概览
简要总结
This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.
详细描述
It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.
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
盲法说明
Open Label
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
- •Documented HIV infection confirmed by western blot or HIV RNA.
- •At least 18 years of age.
- •Less than 1 week of prior antiretroviral therapy.
- •In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.
- •Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
- •HIV RNA > 5000 copies/ml. No restriction on CD4 cell count.
- •A negative urine pregnancy test on the day of initiation of therapy.
排除标准
- •Prior treatment with >1week of antiretroviral therapy.
- •Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
- •HIV RNA < 5000 prior to receiving therapy.
- •Baseline resistance to any of the study regimen drugs on genotype testing.
- •Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
- •Patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening <30mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dL).
- •Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety.
- •A female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded.
- •Inability to obtain signed informed consent from a patient age 18 or older.
- •Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
- •Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and patients who are currently receiving lipid-lowering therapy are excluded.
研究组 & 干预措施
Raltegravir plus Truvada
Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
干预措施: Raltegravir (Drug)
Raltegravir plus Truvada
Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
干预措施: Truvada (Drug)
Lopinavir/Ritonavir plus Truvada
Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
干预措施: Lopinavir/Ritonavir (Drug)
Lopinavir/Ritonavir plus Truvada
Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
干预措施: Truvada (Drug)
结局指标
主要结局
Absolute Change in CD4 Cell Counts
时间窗: 24 and 48 weeks
次要结局
- Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.(24 weeks)
研究者
Gary Simon
Professor of Medicine
George Washington University