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ISRCTN
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ISRCTN59497461
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ClinicalTrials.gov identifier
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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.
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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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01/05/2006
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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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60
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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.
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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) - grant
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Trial website
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Publications
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Contact name
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Prof
J M A
Lange
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Address
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Academic Medical Centre (AMC)
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 566 7868
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Email
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j.lange@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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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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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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20/10/2008
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Date ISRCTN assigned
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23/02/2007
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