A Phase 3 interventional study of Fostemsavir and Dolutegravir (DTG)/ Lamivudine (3TC) in HIV Infections, sponsored by ViiV Healthcare. Recruiting at 4 sites in South Africa. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and 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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 181 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 265 studies on the registry; 16 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with HIV-1 who received the study intervention and completed the protocol-defined treatment period in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies (2020-001029-30, 2020-001426-57), and who continue to receive the study intervention from their respective parent study.
Drug: Fostemsavir · Drug: Dolutegravir (DTG)/ Lamivudine (3TC)
Participants receive oral tablets with the dosages depending on the weight of the participants.
Drug pages: Dolutegravir · Lamivudine
Participants receive oral tablets with the dosages depending on the weight of the participants.
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)
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.
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)
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.
Time frame: Throughout the study period (from rollover visit at Day 1 until the end of study /withdrawal visit)
Plan to share: Yes — Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.viiv-studyregister.com
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2032, 73 months after the start.
Of 57 industry-sponsored phase 3 interventional studies under HIV Infections, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 30. This study's planned 73 months is above that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Fostemsavir · Dolutegravir · Lamivudine