Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
研究概览
简要总结
This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.
详细描述
The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.
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
- •Acute or Early HIV-1 infection
- •HIV-1 RNA > or equal to 500 copies/mL
- •Acceptable safety lab results (specified in protocol)
- •Negative pregnancy test for females
- •Willingness to use contraception (for females of reproductive potential
排除标准
- •Prior receipt of investigational HIV-1 vaccine
- •Use of immunomodulators other than systemic steroids within 30 days before entry
- •Serious medical or psychiatric illness that would interfere with study participation
- •Active drug or alcohol use that would interfere with study participation
- •Allergy/hypersensitivity to raltegravir
- •Pre- or Post-exposure prophylaxis for the exposure that led to HIV-1 acquisition
- •Pregnancy or breastfeeding
- •History of malignancy (other than localized squamous cell or basal cell cancer of the skin)
研究组 & 干预措施
Raltegravir + 3-drug anti-HIV therapy
干预措施: 3-drug anti-HIV therapy (Drug)
Raltegravir + 3-drug anti-HIV therapy
干预措施: Raltegravir (Drug)
3-drug anti-HIV therapy
干预措施: 3-drug anti-HIV therapy (Drug)
结局指标
主要结局
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
时间窗: 96 weeks
次要结局
- CD4+ T-cells(96 weeks)
- Plasma HIV-1 RNA(Baseline to Week 8)
- Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline(From study drug start to 8 weeks after drug discontinuation)
- Tolerability (Discontinuation of raltegravir)(96 weeks)
研究者
Ann Collier
Professor of Medicine
University of Washington