An Open Label Study to Examine the Characteristics of HIV Decay Following Introduction of Combination Antiretroviral Therapy Including Raltegravir During Primary and Chronic HIV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
研究概览
简要总结
The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
详细描述
The study is an open-label study of 3-years duration. This study will be conducted at 4 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. Subjects will be followed for three years with intensive quantification of both plasma RNA and cell associated DNA viral species.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age at least 18 years.
- •Provision of written, informed consent.
- •Screening plasma HIV RNA > 10,000 copies/mL.
- •Screening CD4+ T lymphocyte count > 100 x 10^6)/L.
- •No previous antiretroviral therapy.
- •Haemoglobin > 115 g/L (female) or > 130 g/L (male).
- •Absolute neutrophil count > 1 x 10^9/L.
- •Platelet count > 100 x 10^9/L
- •Serum bilirubin < 1.5 x ULN.
- •Serum alkaline phosphatase < 3 X ULN.
- •Serum aspartate aminotransferase (AST) < 3 X ULN.
- •Serum alanine aminotransferase (ALT) < 3 X ULN.
- •Creatinine clearance > 50mL/min (Creatinine clearance (mL/min) =140 - age x weight creatinine Multiply the result by 1.2 for men).
- •Cohort A: Primary HIV infection:
- •Documented acute or early infection diagnosed by:
- •Acute infection:
- •< 3 bands on Western Blot and any one of: i. positive p24 antigen ii. positive proviral DNA
- •Early infection:
- •i. Positive detuned or BED ELISA result OR ii. Previously negative serology within 6 months of confirmed positive serology.
- •Cohort B: Chronic HIV infection:
- •Documented HIV-infection of at least 12 months duration.
排除标准
- •Pregnancy or breastfeeding.
- •Receipt of investigational products within 1 month of study entry.
- •Receipt of any of the following within 6 months of study entry:
- •interferon alpha or gamma
- •oral corticosteroids (inhaled or topical corticosteroids are permitted)
- •cyclosporin
- •alkylating agents
- •other immunosuppressive agents
- •phenytoin
- •phenobarbital
- •Documented genotypic (IAS 2007) resistance to tenofovir or emtricitabine from any HIV drug resistance test.
- •Any medications contraindicated with Truvada or raltegravir.
- •Significant intercurrent illnesses apart from HIV infection such as viral hepatitis (diagnosed by core hepatitis B antigen and/or positive hepatitis B PCR or positive hepatitis C PCR) or any other condition which in the opinion of the investigator would compromise participation in the study.
- •History of non-traumatic osteoporotic fracture.
研究组 & 干预措施
antiretroviral therapy
tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day.
干预措施: Tenofovir + emtricitabine + raltegravir. (Drug)
结局指标
主要结局
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
时间窗: 12 times within 48 weeks.
change was calculated as the mean of 12 assessments minus the baseline value
次要结局
未报告次要终点
研究者
Sally Hough
Senior Clinical Project Coordinator
Kirby Institute