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NCT02616029 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT02616029: Completed Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT02616029 is a Phase 3 study of HIV-1-infection that has completed, run by Gilead Sciences. The registered enrollment target is 66 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02616029, a Phase 3 study of HIV-1-infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV) -1 reverse transcriptase. This is a two part study. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2.
Primary Outcome
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study.
Conditions Studied
Interventions
- DRUG E/C/F/TAF
Study Locations (20)
Other
- Hopital Sainte Marguerite - Hospital - Marseille
- CHU de Nantes - Nantes
- CHU de Nice-l Archet - Nice
- CHR Orleans la Source - Orléans
- Hopital Saint Louis - Paris
- Hopital Necker les Enfants Malades - Paris
- CHU Tours Service de Médecine Internes et Maladies Infectieuses - Tours
- Universitatsklinikum Essen - Essen
- ICH Study Center- Dedicated Research - Hamburg
- Universitat Mainz - Mainz
- IRCCS A.O.U. San Martino - Genova
- Fondazione IRCCS San Raffaele del Monte Tabor - Milan
- ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - Milan
- Comprensorio Amedeo Di Savoia Birago Di Vische - Torino
- Hospital Universitari Germans Trias i Pujol - Badalona
- Hospital Clinic de Barcelona - Hospital - Barcelona
- Hospital Universitario 12 de Octubre - Hospital - Madrid
Florida
- Midway Immunology & Research Center, LLC - Ft. Pierce
- Orlando Immunology Center - Orlando
- Triple O Research Institute PA - West Palm Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2015-12-17 |
| Est. Completion | 2019-07-11 |
| Phase | Phase 3 |
What the finished NCT02616029 record still lists
NCT02616029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (81% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which E/C/F/TAF is the first listed.
NCT02616029 names 20 study sites across 2 states, led by Other, Florida.
Frequently Asked Questions
What is clinical trial NCT02616029 about?
NCT02616029 is a clinical study titled "Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I". The primary objective of the study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC...
What is the current status of trial NCT02616029?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2015-12-17. Estimated completion is 2019-07-11.
What conditions does trial NCT02616029 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT02616029?
The interventions under investigation include: E/C/F/TAF (DRUG).
Who is sponsoring clinical trial NCT02616029?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02616029 being conducted?
This trial has 20 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02616029's enrollment target sits among peer trials
66 42nd of 71 higher than 30 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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.
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