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NCT01854775 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT01854775: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT01854775 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01854775, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF (Part A), and to evaluate the safety and tolerability of E/C/F/TAF through Week 24 (Part B) in virologically suppressed HIV-1 infection children 6 to \< 12 years weighing \>= 25 kg. The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.
Primary Outcome
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Interventions
- DRUG E/C/F/TAF
- DRUG E/C/F/TAF (Low Dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2013-05-06 |
| Est. Completion | 2025-06-18 |
| Phase | Phase 2 |
What the finished NCT01854775 record still lists
NCT01854775 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which E/C/F/TAF is the first listed.
NCT01854775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01854775 about?
NCT01854775 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children". The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerabilit...
What is the current status of trial NCT01854775?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2013-05-06. Estimated completion is 2025-06-18.
What interventions are being tested in trial NCT01854775?
The interventions under investigation include: E/C/F/TAF (DRUG), E/C/F/TAF (Low Dose) (DRUG).
Who is sponsoring clinical trial NCT01854775?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01854775's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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