Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00337467 | Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression | PHASE3 | COMPLETED | 61 | — | — | Jun 1, 2006 | May 1, 2009 | Jul 19, 2010 | 7 | Spain |
Treatment Failure through Week 48 defined as virologic rebound (HIV RNA \>=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) \>= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA \>=400 c/mL followed by discontinuation of study therapy.
| Arm | Type | Description |
|---|---|---|
| A1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Atazanavir + Ritonavir | DRUG | Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks |
Inclusion Criteria: * On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks). * Absence of evidence or suspected virologic failure on antiretroviral therapy * Absence of known primary mutations in the protease gene * Only 1 highly active a...