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NCT01923311 · ClinicalTrials.gov registry record · Phase 2
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01923311 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 31 participants.
The verdict
NCT01923311, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to \<18 years of age. The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA \< 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA \> 1,000 copies/mL only for participants in Cohort 2, Part A) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA \> 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to \< 18 years old) containing Part B only.
Interventions
- DRUG Background regimen
- DRUG EVG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-08-26 |
| Est. Completion | 2017-11-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01923311
The ClinicalTrials.gov registry entry for NCT01923311 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Background regimen is the first listed.
NCT01923311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01923311 about?
NCT01923311 is a clinical study titled "Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants". The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to \<18 years of age. The study consists of 2 parts: Part A and Part B. Part A will enroll partici...
What is the current status of trial NCT01923311?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2013-08-26. Estimated completion is 2017-11-03.
What interventions are being tested in trial NCT01923311?
The interventions under investigation include: Background regimen (DRUG), EVG (DRUG).
Who is sponsoring clinical trial NCT01923311?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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