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Not yet recruiting NCT07393659

A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment

Phase III Interventional HIV Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fostemsavir, Dolutegravir (DTG)/ Lamivudine (3TC).
Who it may be relevant to
Registry conditions: HIV Infections. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Fostemsavir
    Participants receive oral tablets with the dosages depending on the weight of the participants.
  • Drug Dolutegravir (DTG)/ Lamivudine (3TC)
    Participants receive oral tablets with the dosages depending on the weight of the participants.

Primary outcome measures

  • 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)]
  • 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)]

Eligibility criteria

Inclusion criteria

Participants are eligible to be included in this study only if all the following criteria apply:

  • 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

Participants are excluded from participating in this study if the following criterion applies:

  • Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant's inclusion in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07393659 · 300269

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗