Clinical trial NCT00824421: A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1
Keywords: HIV-1. Treatment Naive
HIV Infections
treatment naive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96
timeFrame: Week 24, 96
measure: Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96
timeFrame: Week 24, 48, 96
measure: Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
timeFrame: Baseline, Week 24, 48, 96
measure: Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
timeFrame: Baseline up to Week 24, 48, 96
measure: Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96
timeFrame: Week 24, 48, 96
measure: Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96
timeFrame: Baseline, Week 24, 48, 96
measure: Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96
timeFrame: Baseline, Week 24, 48, 96
measure: Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96
timeFrame: Day 1 (pre-dose) through Week 24, 48, 96
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to Week 96 or early termination
measure: Population Pharmacokinetic (PK) of Lersivirine
timeFrame: Week 2, 4, 8, 12, 16, 24, 32, 40, 48
measure: Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)
timeFrame: Week 2, 4, 8, 12, 16, 24, 32, 40, 48
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4
measure: Maximum Observed Plasma Concentration (Cmax) of Lersivirine
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
measure: Plasma Concentration of Lersivirine at 24 Hour
timeFrame: 24 hrs post-dose on Week 4
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: Distrito Federal
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa Zulu Natal
city: Namakgale
country: South Africa
facility: Pfizer Investigational Site
state: Limpopo
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: CH-8091 Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Lugano
country: Switzerland
facility: Pfizer Investigational Site
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
city: Crumpsall
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater Manchester
city: Brighton
country: United Kingdom
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: