|- candidate number||0|
|- NTR Number||NTR101|
|- Date ISRCTN created||23-feb-2007|
|- date ISRCTN requested||18-aug-2005|
|- Date Registered NTR||17-aug-2005|
|- Secondary IDs||03/059 MEC |
|- Public Title||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.|
|- Scientific Title||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.|
|- hypothesis||The 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) studied||Human immunodeficiency virus (HIV), Primaire HIV-1 infection|
|- Inclusion criteria||Diagnosis 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;
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);
3. ELISA: HIV-1 specific antibodies positive and positive Western Blot, but with documented negative HIV-1 ELISA in the preceding 180 days.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2003|
|- planned closingdate||1-feb-2012|
|- Target number of participants||173|
|- Interventions||6 or 15 months of highly-active antiretroviral therapy (HAART) initiated during primary HIV-1 infection.|
|- Primary outcome||To 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 outcome||To 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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. J.M.A. Lange|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.M. Prins|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam, IATEC B.V.|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam, Governmental grant|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||17-aug-2005 - 14-aug-2010|