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NCT01691794 · ClinicalTrials.gov registry record · Phase 4
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
A Phase 4 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
NCT01691794: Completed Phase 4 study, sponsored by Bristol-Myers Squibb.
NCT01691794 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 108 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691794, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
Study Summary
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.
Primary Outcome
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild,
Interventions
- DRUG Ritonavir
- DRUG Atazanavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2012-11-30 |
| Est. Completion | 2017-02-20 |
| Phase | Phase 4 |
What the finished NCT01691794 record still lists
NCT01691794 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Ritonavir is the first listed.
NCT01691794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01691794 about?
NCT01691794 is a clinical study titled "Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients". The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therap...
What is the current status of trial NCT01691794?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2012-11-30. Estimated completion is 2017-02-20.
What interventions are being tested in trial NCT01691794?
The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG).
Who is sponsoring clinical trial NCT01691794?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01691794's enrollment target sits among peer trials
108 740th of 2000 higher than 1,256 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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