A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV He… (NCT07393659) | Clinical Trial Compass
RecruitingPhase 3
A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment
South Africa181 participantsStarted 2026-07-21
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who discontinue the study intervention and the reason for discontinuation
Timeframe: Throughout the study period (from rollover visit at Day 1 until the end of study/withdrawal visit)
2
Number of participants with serious adverse events (SAE)
Timeframe: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)
3
Number of participants with adverse events of special interest (AESI)
Timeframe: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)