Dettagli per singolo studio

DEC-NET Serial number IT320
See also: GB454
Published online	20/09/2004 16.29.00
Last updated	27/01/2005 16.43.02

Other protocol ID number
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	HUMAN IMMUNO VIRUS DIS
Experimental drug
Amprenavir Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	3 months - 18 years
Eligibility criteria
Inclusion criteria
. confirmed HIV-infected . currently receiving and stable on the same antiretroviral therapy for at least 1 month; OR, if not on therapy, stopped within the last 2 weeks. . parents/guardians, and children where appropriate, are willing and able to give informed consent . previous exposure to 2 or 3 classes of antiretroviral drugs, or, if exposed to nucleoside analogue reverse transcriptase inhibitors (NRTI) only, either exposed to 3 NRTI or 2 NRTI for more than 2 years. . the paediatrician is likely to change treatment. . most recent HIV RNA result was >2000 copies/ml. . paediatrician and parents are willing to wait 3 weeks for the resistance assay result before switching therapy. . local resistance testing will not be done during the trial
Exclusion criteria
. a previous resistance test, assessing both reverse transcriptase and protease inhibitor drug resistance has been performed while the child is on the current regimen. Children who have had a test on a previous regimen may be enrolled to a maximum recruitment of 30 children. A previous regimen is regarded as a regimen that does not contain ANY drugs currently used for treatment of the child . unlikely to comply with the routine schedule of visits
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Diagnostic
Design	Controlled Randomised
Purpose of study
To evaluate whether the use of resistance testing using a centralised genotypic assay with computer assisted interpretation (VIRCO .virtual phenotype.) to make decisions about a new regimen results in a greater reduction in HIV-1 RNA in HIV infected children than choice.




Summary of study design, objectives, and ongoing research findings
Although potent combination therapies have led to a major advance in the treatment of HIV infection, such therapies may ultimately fail, in part due to the development of drug resistance. Resistance assays have been developed for detecting mutations in the relevant HIV genes (genotypic assays) and for measuring susceptibility to specific drugs (phenotypic assays). To date resistance assays have mainly been used in a research context, but there is growing pressure to introduce them into routine clinical practice. The cost effectiveness of these tests in the longterm still remains to be proven in pharmacoeconomic studies. In children, there have been no clinical trials evaluating the usefulness of resistance testing. PERA is a randomised trial of resistance testing in children in whom the paediatrician has decided to change antiretroviral therapy (ART), and whose most recent viral load is at least 2000 copies/ml. The trial will have 2 Arms. In Arm 1 children will have access to a centralised genotypic assay, with computer assisted interpretation based on a database of linked results from genotypic and phenotypic testing. Children in Arm 2 will have no resistance testing. Children allocated to Arm 1 would have access to resistance testing at trial entry and at any time during follow-up when clinically indicated. The primary analyses will compare HIV-1 RNA viral load in the genotypic testing versus no testing arms at 12 months. To guide health purchasers, a decision-analytic model will be developed to estimate the incremental cost per life-year gained associated with the resistance testing versus no testing.