A Phase 3b, Open-label, Multicenter, Continued Access Study for Participants Transitioning From ViiV Healthcare Sponsored or ViiV Healthcare Collaborative Parent Studies for HIV Treatment
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- ViiV Healthcare
- Enrollment
- 181
- Locations
- 4
- Primary Endpoint
- Number of participants who discontinue the study intervention and the reason for discontinuation
Study Overview
Brief Summary
The purpose of this study is to provide continued access to the study treatment for participants from previous ViiV Healthcare studies who are still benefiting from it and do not have local access after completing the parent study. This continued access will also allow further collection of safety data. Eligible participants are those who completed a ViiV Healthcare-sponsored or collaborative parent study and are currently experiencing clinical benefit. The Sponsor will periodically review the study to consider other treatment access options.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for the parent study (i.e., have not met parent study discontinuation/ withdrawal criteria).
- •Participants or legally authorized representative (LAR) who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable appendix and determined by the Investigator.
- •Participant or LAR is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and this protocol. Where applicable, participants must provide written assent.
Exclusion Criteria
- •Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant's inclusion in the study.
Arms & Interventions
Continued Access Group
Participants with HIV-1 who received the study intervention and completed the protocol-defined treatment period in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies (2020-001029-30, 2020-001426-57), and who continue to receive the study intervention from their respective parent study.
Intervention: Fostemsavir (Drug)
Continued Access Group
Participants with HIV-1 who received the study intervention and completed the protocol-defined treatment period in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies (2020-001029-30, 2020-001426-57), and who continue to receive the study intervention from their respective parent study.
Intervention: Dolutegravir (DTG)/ Lamivudine (3TC) (Drug)
Outcomes
Primary Outcomes
Number of participants who discontinue the study intervention and the reason for discontinuation
Time Frame: Throughout the study period (from rollover visit at Day 1 until the end of study/withdrawal visit)
Number of participants with serious adverse events (SAE)
Time Frame: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)
A SAE is defined as any untoward medical occurrence that, at any dose, results in results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes or a suspected transmission of any infectious agent via an authorized medicinal product.
Number of participants with adverse events of special interest (AESI)
Time Frame: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AESI is defined as an AE of a scientific and medical concern specific to the study intervention, which may require further investigation in order to characterize and understand it.
Secondary Outcomes
No secondary outcomes reported