Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01332227 · ClinicalTrials.gov registry record · Phase 4
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
A Phase 4 study of HIV, Combination Therapy, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 4
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT01332227: Completed Phase 4 study of HIV, Combination Therapy, sponsored by Bristol-Myers Squibb.
NCT01332227 is a Phase 4 study of HIV, Combination Therapy that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 132 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332227, a Phase 4 study of HIV, Combination Therapy, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Primary Outcome
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-
Conditions Studied
Interventions
- DRUG Atazanavir
- DRUG Raltegravir
- DRUG Ritonavir (heat-stable)
- DRUG Tenofovir/Emtricitabine
Study Locations (20)
Other
- Local Institution - Lyon
- Local Institution - Orléans
- Local Institution - Paris
- Local Institution - Paris
- Local Institution - Strasbourg
- Local Institution - Bochum
- Local Institution - Frankfurt
- Local Institution - Frankfurt am Main
- Local Institution - Hamburg
- Local Institution - Munich
- Local Institution - Genova
Florida
- Consultive Medicine - Daytona Beach
- Orange County Health Dept. - Orlando
- Triple O Medical Services, P.A. - West Palm Beach
California
- Eisenhower Medical Center - Palm Springs
- Metropolis Medical Pc - San Francisco
Arkansas
- Health For Life Clinic Pllc - Little Rock
Massachusetts
- The Research Institute - Springfield
New York
- Aids Care - Rochester
Cedex 12
- Local Institution - Paris
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT01332227 record still lists
NCT01332227 is an interventional study that assigns participants to a tested intervention. The registered 132 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 (75% lower).
The record links to 1 condition, with HIV, Combination Therapy appearing as the primary indexed condition, and to 4 interventions - of which Atazanavir is the first listed.
NCT01332227 names 20 study sites across 7 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT01332227 about?
NCT01332227 is a clinical study titled "Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients". The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching t...
What is the current status of trial NCT01332227?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2011-10. Estimated completion is 2014-02.
What conditions does trial NCT01332227 study?
This clinical trial studies the following conditions: HIV, Combination Therapy.
What interventions are being tested in trial NCT01332227?
The interventions under investigation include: Atazanavir (DRUG), Raltegravir (DRUG), Ritonavir (heat-stable) (DRUG), Tenofovir/Emtricitabine (DRUG).
Who is sponsoring clinical trial NCT01332227?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01332227 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01332227's enrollment target sits among peer trials
132 610th of 2000 higher than 1,383 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia