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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00824421 | A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1 | PHASE2 | COMPLETED | 195 | — | — | Feb 1, 2009 | Oct 1, 2011 | Jan 24, 2014 | 31 | Argentina, Australia +7 |
| NCT00348673 | A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061 | PHASE2 | COMPLETED | 49 | — | — | Feb 1, 2006 | Feb 1, 2007 | Oct 18, 2013 | 3 | Germany |
Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid\[HIV-1 RNA\]) levels(log10 copies/milliliter\[copies/mL\])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (\<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.
| Arm | Type | Description |
|---|---|---|
| UK- 453,061 Dose One | EXPERIMENTAL | UK 453,061 Dose One plus Truvada |
| UK-453,061 Dose Two | EXPERIMENTAL | UK 453,061 Dose Two plus Truvada |
| Efavirenz + Truvada | ACTIVE_COMPARATOR | Efavirenz + Truvada |
| Stage 1 | EXPERIMENTAL | - |
| Stage 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| UK-453, 061 | DRUG | UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. |
| EFV +TVA | DRUG | Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD. |
| UK-453,061 | DRUG | Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days |
Inclusion Criteria: * Male or female at least 18 years of age available for a follow-up period of at least 96 weeks. * HIV 1 RNA viral load of greater then 1,000 copies/mL * Negative urine pregnancy test. Exclusion Criteria: * Suspected or documented active, untreated HIV-1 related opportunist in...