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ISRCTN
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ISRCTN59497461
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DOI
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10.1186/ISRCTN59497461
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A randomised, triple-arm study to compare the viral and immunological outcome of highly active anti-retroviral therapy during six versus 15 months versus no treatment in patients with primary human immunodeficiency virus-1 (HIV 1) infection
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Scientific title
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Acronym
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Primo-SHM
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Serial number at source
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NTR101
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Study hypothesis
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The aim of this study is to provide data on the effect of treatment during primary human immunodeficiency virus infection (PHI) on the viral set-point and the optimal duration of such treatment.
As of 10/08/2010 this record was updated with protocol amendments; at this time, the anticipated end date of this trial was extended to 1st February 2012, the initial anticipated end date of this trial was 1st May 2006. At this time, the target number of participants was also increased from 60 to 173.
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Lay summary
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Ethics approval
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Approval received from the AMC Medical Ethics Committee (ref: MEC 03/059).
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Study design
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Randomised, active controlled, parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Human immunodeficiency virus (HIV), primary human immunodeficiency virus-1 (HIV-1) infection
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Participants - inclusion criteria
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Diagnosis of acute/recent human immunodeficiency virus-1 (HIV-1) infection: plasma HIV-1 ribonucleic acid (RNA) load detectable and/or detectable serum p24 antigen and one of the following:
1. Enzyme-linked immunosorbent assay (ELISA): HIV-1 specific antibodies negative, or
2. ELISA: low level antibodies or HIV-1 specific antibodies positive and a negative, incomplete or indeterminate Western Blot (antibodies against a maximum of three of the HIV specific proteins), or
3. ELISA: HIV-1 specific antibodies positive and positive Western Blot, but with documented negative HIV-1 ELISA in the preceding 180 days
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria
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Anticipated start date
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01/05/2003
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Anticipated end date
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01/02/2012
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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173
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Interventions
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Six or 15 months of highly-active anti-retroviral therapy (HAART) initiated during primary HIV-1 infection.
As of 11/08/2010 the status of this record is that inclusion to the trial has stopped and follow-up is ongoing.
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Primary outcome measure(s)
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Plasma HIV-1 RNA at week 96:
1. Magnitude of viral set-point will be evaluated for both treatment groups 36 weeks after treatment discontinuation, and a comparison will be made between all groups at week 96 (= study end)
2. Comparison between all three groups of viral kinetics (including rebound) during the off-treatment periods
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Secondary outcome measure(s)
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1. CD4+ cell counts
2. Safety: (serious) adverse events, HIV related events and death
3. Quality of life
4. Time between diagnosis and start/reinitiation of HAART
5. Time between treatment discontinuation and reinitiation of HAART
In selected groups/individuals:
6. HIV-1 specific CD4+ and CD8+ T-cell response and their state of activation and maturation
7. Humoral immune response parameters
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Sources of funding
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Dutch Government (The Netherlands)
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Trial website
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Publications
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Contact name
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Prof
Dr. J.M.
Prins
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Address
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Academic Medical Centre (AMC)
University of Amsterdam
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 566 4380
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Email
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j.m.prins@amc.uva.nl
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Sponsor
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Academic Medical Centre (AMC) (The Netherlands)
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Address
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University of Amsterdam
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl
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Date applied
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23/02/2007
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Last edited
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11/08/2010
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Date ISRCTN assigned
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23/02/2007
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