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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00144833




Registration number
NCT00144833
Ethics application status
Date submitted
1/09/2005
Date registered
5/09/2005
Date last updated
12/11/2007

Titles & IDs
Public title
Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects
Scientific title
A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure
Secondary ID [1] 0 0
APV102002
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 - fosamprenavir/ritonavir (700mg/100mg BID)
Treatment: Drugs - fosamprenavir/ritonavir (1400mg/100mg BID)
Treatment: Drugs - fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)

Treatment: Drugs: fosamprenavir/ritonavir (700mg/100mg BID)


Treatment: Drugs: fosamprenavir/ritonavir (1400mg/100mg BID)


Treatment: Drugs: fosamprenavir/lopinavir/ritonavir (1400mg/533mg/100mg BID)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure.
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations.
Timepoint [1] 0 0
48 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

- Multiple protease-inhibitors experienced HIV-1 infected individuals experiencing
virological failure and who's virus is not fully resistant to boosted fosamprenavir
and boosted lopinavir based on genotypic resistance tests.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- No full resistance to FPV/r or LPV/r

- Planned use of NNRTIs as part of the study salvage regimen

- Application of additional exclusion criteria as determined by physician.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Clinical Trials Call Center - Darlinghurst
Recruitment hospital [2] 0 0
GSK Clinical Trials Call Center - Carlton
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
France
State/province [5] 0 0
Lagny sur Marne
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
France
State/province [7] 0 0
Saint Denis
Country [8] 0 0
France
State/province [8] 0 0
Strasburg
Country [9] 0 0
France
State/province [9] 0 0
Toulon
Country [10] 0 0
France
State/province [10] 0 0
Vanouvre Les Nancy
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Greece
State/province [13] 0 0
Piraeus
Country [14] 0 0
Italy
State/province [14] 0 0
Liguria
Country [15] 0 0
Italy
State/province [15] 0 0
Lombardia
Country [16] 0 0
Italy
State/province [16] 0 0
Romagna
Country [17] 0 0
Italy
State/province [17] 0 0
Rome
Country [18] 0 0
Italy
State/province [18] 0 0
Torino
Country [19] 0 0
Italy
State/province [19] 0 0
Toscana
Country [20] 0 0
Italy
State/province [20] 0 0
Veneto
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Jerez de la Frontera
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Birmingham
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Brighton
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
For HIV-infected individuals with highly resistant viruses, higher drug levels may be
required to block the virus. This study investigates that concept by comparing the efficacy
of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a
combination of fosamprenavir (increased dose)/lopinavir/ritonavir.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00144833
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
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/ct2/show/NCT00144833