NCT00044577已完成3 期
See Detailed Description
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 77
- 主要终点
- HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
研究概览
简要总结
A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.
详细描述
A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-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
- •Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).
- •Patients must be naive to tenofovir.
- •HIV-1 RNA level > 1000 copies/ml on at least one occasion within 21 days of study entry.
- •A CD4 cell count > 50 cells/mm
- •Specified viral genotypes.
排除标准
- •Pregnant or breast-feeding women.
- •Has an active diagnosis of AIDS.
- •Additional qualifying criteria to be determined by the physician.
结局指标
主要结局
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
时间窗: 48 weeks
次要结局
- Viral load response T-cell count Health Outcomes Resistance
研究者
研究点 (77)
Loading locations...
相似试验
已完成
3 期
Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMDNeovascular Age-related Macular DegenerationNCT03386474Novartis Pharmaceuticals151
进行中（未招募）
2 期
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)HIV InfectionsNCT06741397ViiV Healthcare229
已完成
2 期
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With EpilepsyEpilepsies, PartialEpilepsyNCT00210652SK Life Science, Inc.47
已完成
2 期
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular RosaceaPapulopustular RosaceaNCT01025635LEO Pharma401
已完成
1 期
Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation DiseasesOsteoarthritis of KneeNCT05081921Jagiellonian University192