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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00340080




Registration number
NCT00340080
Ethics application status
Date submitted
19/06/2006
Date registered
21/06/2006
Date last updated
25/01/2010

Titles & IDs
Public title
Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity
Scientific title
A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity
Secondary ID [1] 0 0
PREDICT-1
Secondary ID [2] 0 0
CNA106030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abacavir

Treatment: Drugs: Abacavir


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of clinically-suspected ABC HSR in Caucasians and in different ethnic sub-groups. Sensitivity and specificity, positive and negative predictive value of genetic screening for HLA-B*5701 for susceptibility of HSR.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

- Infected with documented HIV-1.

- Subjects are Abacavir-naive (subjects can be antiretroviral therapy (ART)-naive or
experienced).

- All subjects must have a clinical need for treatment with Abacavir (ABC) or an
ABC-containing product that precedes the decision to participate in the study.

- If subjects are therapy naive they must meet the criteria for commencing HAART
according to local guidelines.

- ABC and ABC-containing products are not recommended during pregnancy. A female is
eligible to enter and participate in the study if she is of:

1. Non-child-bearing potential: women who are surgically sterile or post-menopausal,
the latter indicated by history of no menses for a minimum of 1 year from the
date of the screening visit.

2. Child-bearing potential: women who provide a negative pregnancy test (beta-human
chorionic gonadotrophin; beta-HCG) at Screening and who agree to one of the
following methods of contraception (any contraception method must be used
consistently and correctly, i.e., in accordance with both the approved product
label and the instructions of a physician, during the study period and through
epicutaneous patch testing where appropriate):

- Complete abstinence from intercourse from 4 weeks prior to administration of the
ABC-containing compound, throughout the study, and for at least 4 weeks after
discontinuation of ABC or ABC-containing product.

- Double barrier method (e.g., male condom/spermicide, male condom/diaphragm,
diaphragm/spermicide). Hormonal contraceptives will not be considered sufficient forms
of contraception for this study.

- Any intrauterine device with published data showing that the expected failure rate is
<1% per year.

- Sterilisation (male partner of female subject).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Has previously received ABC-containing therapy.

- Satisfies any contraindications or restrictions to ABC therapy as listed in the
product labels. Treatment with ABC must be in line with the recommendations of the
product label.

- The subject or any of their healthcare providers is aware of the subjects HLA type.

- Has undergone an allogeneic bone marrow transplant.

- Has an active or acute CDC Clinical Category C event at screening. Treatment for the
acute event must have been completed at least 30 days prior to Screening.

- Current severe illness, including liver and renal failure, major organ allograft,
malignancy requiring parenteral chemotherapy that can not be discontinued for the
duration of the trial, or any other conditions which, in the opinion of the
Investigator, would make the patient unsuitable for the study.

- Any laboratory abnormality at Screening which, in the opinion of the Investigator,
should preclude the subject's participation in the study.

- Pregnant women or women who are breastfeeding.

- Any immunisation within 30 days prior to Day 1.

- Subject is, in the opinion of the Investigator, unable to complete the 6 week
Observation period and the EPT assessments as required.

- Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents
within 28 days prior to Screening, or has an anticipated need for these agents within
the study period.

- Subject is enrolled in one or more investigational drug/vaccine protocols.

- In France, an eligible subject is neither affiliated with nor a beneficiary of a
social security category.

- A subject will not be eligible for progression to Baseline (Day 1) if any of the
following criteria apply:

- A positive result for HLA-B*5701 in those subjects randomised to the genetic screening
arm.

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 4
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Miami
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4220 - Miami
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
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Austria
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Innsbruck
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Austria
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Linz
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Salzburg
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Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of
abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from
Europe, Australia and other countries as applicable. The study has two (co-primary)
objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results
in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic
screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART,
results in a significantly lower incidence of immunologically-confirmed HSR versus current
standard of care (no genetic screening or patch testing). The study consists of up to a
28-day screening period, a randomised observation period (Day 1 through Week 6) and, for
subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an
epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one
of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control)
and a Genetic Screening Arm (prospective genetic screening). Subjects identified as
HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be
excluded from further study. Subjects who experience suspected ABC HSR during the 6-week
observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6
weeks later.
Trial website
https://clinicaltrials.gov/show/NCT00340080
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MB BS MRCP FFPM
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
Other publications