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Adjusted LOA
ML Risk
UK-453,061 · 2 trials · 1 indication
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...
UK-453,061 is an investigational small molecule developed by Pfizer for the treatment of HIV-1 infection. It was studied in Phase 2 clinical trials, both as monotherapy and in combination with Truvada, in patients with HIV-1. It is not an approved medicine and remains a clinical-stage research compound.
UK-453,061 was studied for the treatment of HIV-1 infection in adults. One Phase 2 trial evaluated different doses of UK-453,061 plus Truvada compared with efavirenz plus Truvada in patients not previously treated for HIV-1. Another trial assessed its pharmacodynamics, pharmacokinetics, safety and tolerability in asymptomatic HIV-infected patients.
Pfizer, Inc. (ticker PFE) is the developer of UK-453,061. Pfizer sponsored both Phase 2 studies of the compound in HIV-1, including the dose-ranging combination trial and the earlier pharmacodynamic and pharmacokinetic study in asymptomatic HIV-infected patients.
UK-453,061 reached Phase 2 clinical development. Both of its recorded trials were Phase 2 studies, and both are now completed. There are no active trials of UK-453,061 listed, and the compound is not an approved treatment for HIV-1.
UK-453,061 was evaluated in two completed Phase 2 trials. NCT00824421 compared different doses of UK-453,061 plus Truvada against efavirenz plus Truvada in 195 previously untreated HIV-1 patients across nine countries. NCT00348673 studied pharmacodynamics, pharmacokinetics, safety and toleration in 49 asymptomatic HIV-infected male patients in Germany.
Yes. UK-453,061 and UK-453, 061 refer to the same Pfizer compound. The spacing in the second form reflects how the name appears in some trial titles, such as the Phase 2 study of different doses of UK-453, 061 plus Truvada compared with efavirenz plus Truvada in HIV-1 patients.