CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
UK-453, 061 +2 moredrug
Likely dose
UK-453, 061 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00824421
NCT00824421Phase 2Completed
CompareCT.gov

A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects

Pfizer·interventional·Posted Jan 16, 2009·Updated Jan 24, 2014

In Brief

A Phase 2 clinical trial evaluating UK-453, 061 and EFV +TVA for HIV-1. Completed, enrolled 195 participants across 31 sites in 9 countries.

Detailed Summary

This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1
CountriesArgentina, Australia, Canada, Italy, Mexico, Poland, South Africa, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2009
Enrollment StartFeb 1, 2009
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.5 years ago

Interventions

UK-453, 061drug

UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

UK-453, 061drug

UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD.

EFV +TVAdrug

Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.