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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
ISRCTN ISRCTN59497461
DOI 10.1186/ISRCTN59497461
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym Primo-SHM
Serial number at source NTR101
Study hypothesis 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.
Lay summary
Ethics approval Approval received from the AMC Medical Ethics Committee (ref: MEC 03/059).
Study design Randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Human immunodeficiency virus (HIV), primary human immunodeficiency virus-1 (HIV-1) infection
Participants - inclusion criteria 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
Participants - exclusion criteria Does not comply with the above inclusion criteria
Anticipated start date 01/05/2003
Anticipated end date 01/02/2012
Status of trial Completed
Patient information material
Target number of participants 173
Interventions 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.
Primary outcome measure(s) 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
Secondary outcome measure(s) 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
Sources of funding Dutch Government (The Netherlands)
Trial website
Publications
Contact name Prof  Dr. J.M.  Prins
  Address Academic Medical Centre (AMC)
University of Amsterdam
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 566 4380
  Email j.m.prins@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (The Netherlands)
  Address University of Amsterdam
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl
Date applied 23/02/2007
Last edited 11/08/2010
Date ISRCTN assigned 23/02/2007
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