NCT00046176已完成3 期
A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretroviral Experienced Patients.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 57
- 主要终点
- Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.
研究概览
简要总结
This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.
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
- •Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at least 24 weeks.
- •NOTE: Subjects who have required a change in initial protease inhibitor (PI) or NNRTI therapy due to intolerance (not treatment failure) are eligible. Subject must be on a stable regimen of the second PI or NNRTI therapy for at least 6 months before enrollment in this study.
- •Plasma HIV-1 RNA less than 400 copies/mL for at least 3 months immediately preceding the screening visit, and at screening.
- •CD4+ cell count of at least 50 cells/mm3 at screening.
- •Written informed consent to participate in the study before participation.
- •Male or female (Females of child-bearing potential must have a negative serum pregnancy test at screening and agree to an acceptable method of contraception.)
排除标准
- •History of a CDC Clinical Category C event requiring treatment (not including cutaneous Kaposi's sarcoma) within 45 days of the screening visit. Treatment for the acute event must have been completed at least 30 days before screening.
- •Subject is enrolled in one or more investigational drug studies which may impact HIV RNA suppression.
- •Subject is unable to complete the 48-week dosing period, evaluations and assessments.
- •Subject is pregnant or breastfeeding.
- •History of clinically relevant inflammation of the pancreas or hepatitis within 6 months prior to screening.
- •Subject suffers from a serious medical condition, such as diabetes or heart problem.
- •Pre-existing mental, physical, or substance abuse disorder.
- •History of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction.
- •Abnormal laboratory results within 28 days before the first dose of study medication.
- •Required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days before screening, or will need these during the study.
- •Subject requires treatment with immunomodulating drugs such as systemic corticosteroids, interleukins, vaccines, or interferons within 28 days prior to screening, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
- •Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.
- •Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of screening.
- •Subject has a history of allergy to any of the study drugs.
结局指标
主要结局
Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.
时间窗: 48 weeks
次要结局
- Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance(48 weeks)
研究者
研究点 (57)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil AloneEssential HypertensionNCT01456169Takeda507
已完成
3 期
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without CirrhosisHepatitis C Virus InfectionNCT02114177Janssen Infectious Diseases BVBA310
已完成
3 期
A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male VolunteersFeverNCT02761980Pfizer290
撤回
3 期
Study Comparing 3 Formulations to Evaluate the Efficacy and Safety of the Inflammatory Symptoms of the Upper Respiratory Tract, in Children Between 2 and 6 Years OldCommon ColdNCT00967759Ache Laboratorios Farmaceuticos S.A.
已完成
1 期
A Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608, and HCP1306 in Healthy Male Subjects.HealthyNCT04081844Hanmi Pharmaceutical Company Limited31