EUCTR2006-005579-16-FR进行中（未招募）1 期
Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1 Infected Adult Subjects.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject is =18 years of age
- •2. Subject is antiretroviral-naïve (defined as having =14 days of prior therapy with any antiretroviral agent).
- •3. Subject has plasma HIV-1 RNA =1,000 copies/mL at screening.
- •4. Subject is willing and able to understand and provide written informed consent prior to participation in this study.
- •5. A female is eligible to enter and participate in the study if she is of:
- •a. Non-childbearing potential (i.e., physiologically incapable of becoming
- •pregnant, including any female who is post-menopausal); or,
- •b. Child-bearing potential, has a negative pregnancy test (serum ß-HCG) at screen
- •and agrees to one of the following methods of contraception (any contraception
- •method must be used consistently and correctly, i.e., in accordance with both the
- •approved product label and the instructions of a physician):
- •- Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, throughout the study, and for at least 2 weeks after discontinuation of all study medications
- •- Double barrier method (male condom/spermicide, male condom/diaphragm,
- •diaphragm/spermicide). Hormonal contraception will not be permitted in this study
- •- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year.
- •- Sterilization (female subject or male partner of female subject).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject is in the initial acute phase of a CDC Clinical Category C infection at
- •Baseline. Subjects may be enrolled provided they are receiving treatment for such
- •infections and are clinically improving at the Baseline visit.
- •2. Subject is enrolled in one or more investigational drug protocols, which may impact
- •HIV RNA suppression.
- •3. Subject is either pregnant or breastfeeding.
- •4. Subject has an estimated creatinine clearance < 50 mL/min via the Cockcroft-Gault
- •method [Cockcroft, 1976]. This test may be repeated once within the 45-day
- •screening window.
- •5. Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN) or
- •hepatic impairment as determined by Child-Pugh Score = 5.
- •6. Subject is receiving, or has received within 90 days prior to screen, any lipid
- •lowering agent, including drugs from the following classes: HMG-CoA reductase
- •inhibitors (statins), niacin, fibrates, bile acid sequestrants, and/or fish oil
- •supplements. Subjects anticipated to require initiation of therapy with these agents
- •within 12 weeks of Baseline are not eligible to participate.
- •7. Subject has evidence of genotypic (as defined by the current ANRS AC-11
- •algorithm) resistance at screening or prior documented evidence of genotypic and/or
- •phenotypic (above threshold for reduced susceptibility) resistance to
- •amprenavir/ritonavir, abacavir or lamivudine.
研究者
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