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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00824421




Registration number
NCT00824421
Ethics application status
Date submitted
15/01/2009
Date registered
16/01/2009
Date last updated
24/01/2014

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
A5271015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UK-453, 061
Treatment: Drugs - UK-453, 061
Treatment: Drugs - EFV +TVA

Experimental: UK- 453,061 Dose One - UK 453,061 Dose One plus Truvada

Experimental: UK-453,061 Dose Two - UK 453,061 Dose Two plus Truvada

Active comparator: Efavirenz + Truvada - Efavirenz + Truvada


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

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

Treatment: Drugs: EFV +TVA
Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96
Timepoint [1] 0 0
Week 24, 96
Secondary outcome [2] 0 0
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96
Timepoint [2] 0 0
Week 24, 48, 96
Secondary outcome [3] 0 0
Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
Timepoint [3] 0 0
Baseline, Week 24, 48, 96
Secondary outcome [4] 0 0
Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96
Timepoint [4] 0 0
Baseline up to Week 24, 48, 96
Secondary outcome [5] 0 0
Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96
Timepoint [5] 0 0
Week 24, 48, 96
Secondary outcome [6] 0 0
Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96
Timepoint [6] 0 0
Baseline, Week 24, 48, 96
Secondary outcome [7] 0 0
Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96
Timepoint [7] 0 0
Baseline, Week 24, 48, 96
Secondary outcome [8] 0 0
Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96
Timepoint [8] 0 0
Day 1 (pre-dose) through Week 24, 48, 96
Secondary outcome [9] 0 0
Number of Participants With Laboratory Test Abnormalities
Timepoint [9] 0 0
Baseline up to Week 96 or early termination
Secondary outcome [10] 0 0
Population Pharmacokinetic (PK) of Lersivirine
Timepoint [10] 0 0
Week 2, 4, 8, 12, 16, 24, 32, 40, 48
Secondary outcome [11] 0 0
Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)
Timepoint [11] 0 0
Week 2, 4, 8, 12, 16, 24, 32, 40, 48
Secondary outcome [12] 0 0
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine
Timepoint [12] 0 0
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4
Secondary outcome [13] 0 0
Maximum Observed Plasma Concentration (Cmax) of Lersivirine
Timepoint [13] 0 0
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
Secondary outcome [14] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine
Timepoint [14] 0 0
0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4
Secondary outcome [15] 0 0
Plasma Concentration of Lersivirine at 24 Hour
Timepoint [15] 0 0
24 hrs post-dose on Week 4

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
Italy
State/province [5] 0 0
Torino
Country [6] 0 0
Mexico
State/province [6] 0 0
Distrito Federal
Country [7] 0 0
Poland
State/province [7] 0 0
Bydgoszcz
Country [8] 0 0
Poland
State/province [8] 0 0
Gdansk
Country [9] 0 0
Poland
State/province [9] 0 0
Lodz
Country [10] 0 0
Poland
State/province [10] 0 0
Warszawa
Country [11] 0 0
South Africa
State/province [11] 0 0
Gauteng
Country [12] 0 0
South Africa
State/province [12] 0 0
Kwa Zulu Natal
Country [13] 0 0
South Africa
State/province [13] 0 0
Limpopo
Country [14] 0 0
South Africa
State/province [14] 0 0
Western Cape
Country [15] 0 0
South Africa
State/province [15] 0 0
Pretoria
Country [16] 0 0
Switzerland
State/province [16] 0 0
CH-8091 Zurich
Country [17] 0 0
Switzerland
State/province [17] 0 0
Lugano
Country [18] 0 0
Switzerland
State/province [18] 0 0
St. Gallen
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Greater Manchester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Brighton
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Edinburgh
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00824421
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00824421