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A randomized, triple-arm study to compare the viral and immunological outcome of HAART during 6 versus 15 months versus no treatment in patients with primary HIV 1 infection.


- candidate number0
- NTR NumberNTR101
- ISRCTNISRCTN59497461
- Date ISRCTN created23-feb-2007
- date ISRCTN requested18-aug-2005
- Date Registered NTR17-aug-2005
- Secondary IDs03/059  MEC
- Public TitleA randomized, triple-arm study to compare the viral and immunological outcome of HAART during 6 versus 15 months versus no treatment in patients with primary HIV 1 infection.
- Scientific TitleA randomized, triple-arm study to compare the viral and immunological outcome of HAART during 6 versus 15 months versus no treatment in patients with primary HIV 1 infection.
- ACRONYMPrimo-SHM
- hypothesisThe aim of this study is to provide data on the effect of treatment during PHI on the viral set-point and the optimal duration of such treatment.
- Healt Condition(s) or Problem(s) studiedHuman immunodeficiency virus (HIV), Primaire HIV-1 infection
- Inclusion criteriaDiagnosis of acute/ recent HIV-1 infection: plasma HIV-1 RNA load detectable and/or detectable serum p24 antigen and one of the following:
1. 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.
- Exclusion criteria1. Previous test result with HIV-1 RNA detectable or P24 antigen positive > 180 days before presentation;
2. For female subjects: pregnancy (positive urine pregnancy test) or breast feeding.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2003
- planned closingdate1-feb-2012
- Target number of participants173
- Interventions6 or 15 months of highly-active antiretroviral therapy (HAART) initiated during primary HIV-1 infection.
- Primary outcomeTo evaluate the effect of 6 or 15 months of treatment with a quadruple combination of HAART versus no treatment in PHI. Efficacy will be evaluated by:
1. the viral set-point reached for the three groups and viral rebound kinetics after treatment discontinuation for the two treatment groups.
2. the time that patients can remain off therapy after treatment discontinuation.
- Secondary outcomeTo evaluate:
1. the effect of treatment on plasma viral load and CD4+ T cells.
2. the effect of no treatment versus a treatment duration of 6 versus 15 months on the kinetics of HIV-1 specific CD4+ and CD8+ T-cell responses and their state of maturation, activation and proliferative capacity.
3. the development and efficacy of the humoral immune response.
4. the quality of life.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. J.M.A. Lange
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Prins
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, IATEC B.V.
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Governmental grant
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-aug-2005 - 14-aug-2010


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