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NCT02105987 · ClinicalTrials.gov registry record · Phase 3
A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 555
- Enrollment target
NCT02105987: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT02105987 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 555 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02105987, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 555 participants
- Enrollment target
Study Summary
This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared with continuing the subject's current suppressive regimen through 24 weeks. The study will be conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI). Eligible subjects will be randomly assigned 1:1 to continue their current regimen (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects) once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24 weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir (FPV/r) or tipranavir/ritonavir (TPV/r).
Primary Outcome
The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a "virology first" hierarchy. Virologic Success (e.g., \<50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use
Interventions
- DRUG ABC/DTG/3TC FDC
- DRUG Ongoing cART regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT02105987 record still lists
NCT02105987 is an interventional study that assigns participants to a tested intervention. The registered 555 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which ABC/DTG/3TC FDC is the first listed.
NCT02105987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02105987 about?
NCT02105987 is a clinical study titled "A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen". This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams (mg)/Dolutegravir(DTG) 50 mg/Lamivudi...
What is the current status of trial NCT02105987?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2014-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02105987?
The interventions under investigation include: ABC/DTG/3TC FDC (DRUG), Ongoing cART regimen (DRUG).
Who is sponsoring clinical trial NCT02105987?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02105987's enrollment target sits among peer trials
555 676th of 2000 higher than 1,323 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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