NCT00398125已完成2 期
A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Change in viral load
研究概览
简要总结
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
- •Baseline CD4 cell count greater than
- •Females must be of non-childbearing potential
- •Not have received antiretroviral therapy in the 12 weeks prior to first dose.
排除标准
- •Must not be infected with hepatitis B or C.
- •Patients must not have any acute laboratory abnormality.
- •Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
结局指标
主要结局
Change in viral load
时间窗: from Day 1 to Day 11
Amount of drug in blood
时间窗: on Days 1 and 10.
次要结局
- Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients(throughout the study)
研究者
研究点 (12)
Loading locations...
相似试验
进行中（未招募）
1 期
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)HIVTuberculosisNCT05122767The Aurum Institute NPC92
已完成
1 期
A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated VolunteersHIV InfectionsNCT00002261Bristol-Myers Squibb
已完成
1 期
Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)HIV InfectionsRespiratory Tract InfectionsNCT03435146The Aurum Institute NPC135
已完成
3 期
Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)HIV InfectionsNCT03446573ViiV Healthcare743
已完成
1 期
Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNAHIV InfectionsNCT03181789National Institute of Allergy and Infectious Diseases (NIAID)56