NCT00936715已完成2 期
A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Number of Participants Who Had Access to, and Received the Intervention
研究概览
简要总结
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study.
- •A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than two years post-menopausal).
- •All sexually active female individuals who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
- •Male individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
FTC/TDF
Experimental
干预措施: FTC/TDF (Drug)
结局指标
主要结局
Number of Participants Who Had Access to, and Received the Intervention
时间窗: Up to 240 weeks
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
次要结局
未报告次要终点
研究者
相似试验
已完成
2 期
Ixazomib Rollover StudyMultiple MyelomaLymphomaAmyloidosisNCT02924272Takeda32
已完成
4 期
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male ParticipantsHealthyNCT02530060Janssen Pharmaceutical K.K.8
已完成
4 期
Bictegravir/Emtricitabine/Tenofovir Alafenide Plus DoravirineHIV-1-infectionNCT04538040Quest Clinical Research20
Enrolling By Invitation
3 期
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With CardiomyopathyTransthyretin Amyloidosis (ATTR) With CardiomyopathyNCT06679946Alnylam Pharmaceuticals700
Approved For Marketing
不适用
Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate ToxicityNeoplasmsNCT00481559BTG International Inc.