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Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
NCT03016533 · View on ClinicalTrials.gov ↗
Study Summary
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir. This is a phase 3b, non-randomized, open-label, multi-center, two treatment rollover study. The primary objective of this pediatric interventional study is to provide continued access to age appropriate formulations of investigational product (dolutegravir), either as Tivicay or as part of fixed dose combination ABC/DTG/3TC, for eligible participants who previously participated in parent studies P1093 (NCT01302847) or P2019 (NCT03760458) and who cannot locally access age appropriate formulations of dolutegravir or ABC/DTG/3TC in the public sector. The P1093 study was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of dolutegravir in combination with optimized background regimens in human immunodeficiency virus type 1 (HIV-1) experienced adolescents and children as well as treatment naïve infants and toddlers. The P2019 study was designed to evaluate PK, safety, tolerability and antiviral activity of ABC/DTG/3TC dispersible and immediate release tablets in HIV-1-infected children. Participants who have tolerated investigational product in the parent studies without any significant toxicity or signs of virologic failure leading to the permanent discontinuation of investigational product and withdrawal from the parent study will be considered for this open label continued access study. Participants will receive their age/weight appropriate dose of investigational product as defined in the parent study. The duration of participation in the study will extend until age appropriate formulations of Tivicay or ABC/DTG/3TC receive local (by country) regulatory approval and are available in those countries from another source (e.g. government programs, aid programs, assistance programs, etc.) or the participant is n
Conditions Studied
Interventions
- DRUG Dolutegravir film-coated tablets
- DRUG Dolutegravir film-coated dispersible tablets
- DRUG ABC/DTG/3TC immediate release tablets
- DRUG ABC/DTG/3TC film-coated dispersible tablets
Study Locations (17)
Other
- GSK Investigational Site — Gaborone
- GSK Investigational Site — Belo Horizonte
- GSK Investigational Site — Nova Iguaçu
- GSK Investigational Site — RibeirAo PretoSP
- GSK Investigational Site — Rio de Janeiro
- GSK Investigational Site — Cape Town
- GSK Investigational Site — Johannesburg
- GSK Investigational Site — Soweto
- GSK Investigational Site — Umlazi
- GSK Investigational Site — Moshi
- GSK Investigational Site — Bangkok
- GSK Investigational Site — Chiang Mai
- GSK Investigational Site — Chiang Rai
- GSK Investigational Site — Harare
California
- GSK Investigational Site — Los Angeles
Florida
- GSK Investigational Site — Fort Lauderdale
Tennessee
- GSK Investigational Site — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-06-06 |
| Est. Completion | 2024-12-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03016533
The ClinicalTrials.gov registry entry for NCT03016533 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions — of which Dolutegravir film-coated tablets is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03016533 reports 17 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03016533 about?
NCT03016533 is a clinical study titled "Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019". Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir. This is a phase 3b, non-randomized, open-label, multi-center, two treatment ro...
What is the current status of trial NCT03016533?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2017-06-06. Estimated completion is 2024-12-24.
What conditions does trial NCT03016533 study?
This clinical trial studies the following conditions: HIV Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03016533?
The interventions under investigation include: Dolutegravir film-coated tablets (DRUG), Dolutegravir film-coated dispersible tablets (DRUG), ABC/DTG/3TC immediate release tablets (DRUG), ABC/DTG/3TC film-coated dispersible tablets (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03016533?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03016533 being conducted?
This trial has 17 study locations across California, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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