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
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
Study Sites (1)
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