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Also known as UK-453, 061
UK-453, 061 · 3 trials · 2 indications
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 | - |
| UK-453,061 | ACTIVE_COMPARATOR | - |
| Raltegravir | ACTIVE_COMPARATOR | - |
| UK-453,061 plus Raltegravir | 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 |
| Raltegravir | DRUG | Raltegravir 400 mg twice daily for 10 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, Inc. (PFE) for the treatment of HIV-1 infection. It has been studied in Phase 2 clinical trials in patients with HIV-1 and in Phase 1 trials in healthy volunteers. It is not an approved medicine and remains in clinical development.
UK-453,061 was studied as an antiretroviral treatment for HIV-1 in adults who had not previously been treated for the infection. In a Phase 2 trial it was given in combination with Truvada and compared against efavirenz plus Truvada. It is investigational and has not been approved for any use.
UK-453,061 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program, including a Phase 2 combination study in HIV-1 patients and a Phase 1 drug interaction study with raltegravir.
UK-453,061 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory authority. The Phase 2 program evaluated the compound in HIV-1 patients, and the studies listed for this asset are completed with no trials currently active.
UK-453,061 has been studied in completed trials including NCT00824421, a Phase 2 study of different doses of UK-453,061 plus Truvada versus efavirenz plus Truvada in previously untreated HIV-1 patients, and NCT00784420, a Phase 1 drug interaction study with raltegravir in healthy volunteers. A further Phase 2 study was registered as NCT00348673.
Yes. UK-453,061 and UK-453, 061 refer to the same investigational compound from Pfizer. The two forms differ only in punctuation and spacing, and both appear in trial records for the same HIV-1 program, including the Phase 2 study NCT00824421 and the Phase 1 interaction study NCT00784420.