EUCTR2020-001191-14-FR进行中（未招募）1 期
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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
- •Type of Participant and Disease Characteristics
- •1. Is currently receiving DOR/ISL adult FDC tablet in a Merck-sponsored clinical study and has completed the last treatment visit.
- •2. Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
- •Demographics
- •3. Is male or female and =35 kg at the time of signing the informed consent/assent.
- •Contraception/Pregnancy
- •1. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 6 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention.
- •- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •- Additional requirements for pregnancy testing during and after study intervention are in Appendix 2.
- •- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •- Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Informed Consent/Assent
- •4. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1855
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Concomitant Therapy
- •1. Is taking or is anticipated to require any prohibited therapies listed in the protocol from 14 days prior to Day 1 through the study treatment period.
研究者
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