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NCT01335698 · ClinicalTrials.gov registry record · Phase 3
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
A Phase 3 study of HIV, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT01335698: Completed Phase 3 study of HIV, sponsored by Bristol-Myers Squibb.
NCT01335698 is a Phase 3 study of HIV that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 160 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01335698, a Phase 3 study of HIV, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.
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.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Atazanavir Sulphate
Study Locations (20)
Other
- Local Institution - Oaxaca City
- Local Institution - Puebla City
- Local Institution - Warsaw
- Local Institution - Bucharest
- Local Institution - Saint Petersburg
- Local Institution - Saint Petersburg
Buenos Aires
- Local Institution - Buenos Aires, Bs As
- Local Institution - Bunos Aires
Rio Grande do Sul
- Local Institution - Porto Alegre
- Local Institution - Porto Alegre
Santiago Metropolitan
- Local Institution - Santiago
- Local Institution - Santiago
Jalisco
- Local Institution - Guadalajara
- Local Institution - Guadalajara
District of Columbia
- Children'S National Medical Center - Washington D.C.
New York
- SUNY Upstate Medical University - Syracuse
Pernambuco
- Local Institution - Recife
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-05-27 |
| Est. Completion | 2018-01-22 |
| Phase | Phase 3 |
What the finished NCT01335698 record still lists
NCT01335698 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (64% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Ritonavir is the first listed.
NCT01335698 names 20 study sites across 11 states, led by Other, Buenos Aires, Rio Grande do Sul.
Frequently Asked Questions
What is clinical trial NCT01335698 about?
NCT01335698 is a clinical study titled "Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients". The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.
What is the current status of trial NCT01335698?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2011-05-27. Estimated completion is 2018-01-22.
What conditions does trial NCT01335698 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01335698?
The interventions under investigation include: Ritonavir (DRUG), Atazanavir Sulphate (DRUG).
Who is sponsoring clinical trial NCT01335698?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01335698 being conducted?
This trial has 20 study locations across District of Columbia, New York, Buenos Aires, Pernambuco, Rio Grande do Sul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01335698's enrollment target sits among peer trials
160 128th of 303 higher than 175 of 303 other HIV trials
participants (enrollment target), bucketed by value
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