Continued access for people who benefited from ViiV HIV treatment after parent studies
Official title: 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
Run by ViiV Healthcare · NCT07393659 · Data updated 2026-11-12
This study lets people who benefited from a ViiV HIV treatment continue receiving it if they don’t have local access after completing a parent study.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 181 (estimated) |
| Sponsor | ViiV Healthcare Industry-sponsored |
| Locations | 4 sites (Durban, KwaZulu-Natal and 3 other locations) |
| Status | Recruiting |
| Started | July 21, 2026 |
| Main results expected | September 14, 2032 |
| Study ends | September 14, 2032 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07393659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Individuals who completed a ViiV parent study, are still benefiting from the treatment, and have no local access after the parent study.
✕Probably not a fit
Participants who have discontinued the parent study for reasons unrelated to benefit or who have no ongoing clinical benefit may not receive additional benefit from continued access.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, Phase 3 program providing continued access to Fostemsavir and DTG/3TC for participants who completed a ViiV-sponsored or collaborative parent study and still benefit. The study collects ongoing safety data while allowing continued treatment access. Eligible participants must have completed the parent protocol, remain clinically benefiting, and consent to ongoing visits and treatment procedures. The sponsor may periodically review the plan to consider additional treatment access options. Sites are located in Durban, Jouberton, and Gauteng in South Africa.
Why it matters
Potential benefit: Participants may maintain their current HIV treatment and receive ongoing safety monitoring while access to therapy continues.
How similar studies have gone: Previous programs of continued access for beneficial therapies have shown safety data collection is feasible, but this specific approach with Fostemsavir/DTG/3TC is not widely published.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
GSK Investigational Site
Durban, KwaZulu-Natal, South Africa Recruiting -
GSK Investigational Site
Jouberton, Matlosana, South Africa Recruiting -
GSK Investigational Site
Gauteng, South Africa Recruiting -
GSK Investigational Site
Johannesburg, South Africa Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.