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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 being studied for the treatment of HIV-1 infection. It has been evaluated in Phase 2 clinical trials in asymptomatic HIV-infected patients and in treatment-naive patients, where it was compared against efavirenz plus Truvada. It is not approved and remains in clinical development.
UK-453,061 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of the drug in HIV-1 infection and in healthy volunteers.
UK-453,061 is in Phase 2 clinical development for HIV-1 infection. It has completed two Phase 2 trials and one Phase 1 trial, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
UK-453,061 has completed three clinical trials. NCT00348673 was a Phase 2 study in asymptomatic HIV-1 infected patients in Germany. NCT00784420 was a Phase 1 drug interaction study with raltegravir in healthy volunteers in the United States. NCT00824421 was a Phase 2 study comparing different doses of UK-453,061 plus Truvada to efavirenz plus Truvada in treatment-naive HIV-1 patients across multiple countries.
UK-453,061 is an investigational compound and is not the same as any marketed HIV drug. It has been studied under this code name in clinical trials, and no alternative brand or generic name has been established. It remains in clinical development and is not available commercially.