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Clinical Trials/NCT00824421
NCT00824421CompletedPhase 2

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

Pfizer1 site in 1 country195 target enrollmentStarted: February 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Pfizer
Enrollment
195
Locations
1
Primary Endpoint
Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48

Study Overview

Brief 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 infection or other condition requiring acute therapy at the time of randomization.
  • Subjects with acute Hepatitis B and/or C within 30 days of randomization.
  • Absolute CD4 count <200 cells/mm3.

Arms & Interventions

UK- 453,061 Dose One

Experimental

UK 453,061 Dose One plus Truvada

Intervention: UK-453, 061 (Drug)

UK-453,061 Dose Two

Experimental

UK 453,061 Dose Two plus Truvada

Intervention: UK-453, 061 (Drug)

Efavirenz + Truvada

Active Comparator

Efavirenz + Truvada

Intervention: EFV +TVA (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48

Time Frame: Week 48

Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.

Secondary Outcomes

  • Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96(Week 24, 96)
  • Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96(Week 24, 48, 96)
  • Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
  • Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96(Baseline up to Week 24, 48, 96)
  • Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96(Week 24, 48, 96)
  • Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
  • Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
  • Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96(Day 1 (pre-dose) through Week 24, 48, 96)
  • Number of Participants With Laboratory Test Abnormalities(Baseline up to Week 96 or early termination)
  • Population Pharmacokinetic (PK) of Lersivirine(Week 2, 4, 8, 12, 16, 24, 32, 40, 48)
  • Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)(Week 2, 4, 8, 12, 16, 24, 32, 40, 48)
  • Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine(0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4)
  • Maximum Observed Plasma Concentration (Cmax) of Lersivirine(0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine(0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4)
  • Plasma Concentration of Lersivirine at 24 Hour(24 hrs post-dose on Week 4)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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