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NCT Number: NCT07393659

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

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.

Recruiting

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Durban, KwaZulu-Natal, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fostemsavir

Drug

Participants receive oral tablets with the dosages depending on the weight of the participants.

Dolutegravir (DTG)/ Lamivudine (3TC)

Drug

Participants receive oral tablets with the dosages depending on the weight of the participants.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study 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

Acronym: PATH

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Feb 6, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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