A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment
Recruiting · NCT07393659 · Interventional (participants receive a specific treatment) · Lead sponsor: ViiV Healthcare
View the official record on ClinicalTrials.gov →Interventions studied
Dolutegravir (DTG)/ Lamivudine (3TC)Fostemsavir
What this trial is about
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 take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
4 locations listed.
- GSK Investigational Site - Gauteng, South Africa
- GSK Investigational Site - Johannesburg, South Africa
- GSK Investigational Site - Durban, KwaZulu-Natal, South Africa
- GSK Investigational Site - Jouberton, Matlosana, South Africa