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.
ID
Bron
Verkorte titel
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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: <br>
1. the viral set-point reached for the three groups and viral rebound kinetics after treatment discontinuation for the two treatment groups.<br>
2. the time that patients can remain off therapy after treatment discontinuation.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
6 or 15 months of highly-active antiretroviral therapy (HAART) initiated during primary HIV-1 infection.
Publiek
P.O. Box 22660
J.M.A. Lange
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667868
j.lange@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
J.M.A. Lange
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667868
j.lange@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL70 |
| NTR-old | NTR101 |
| Ander register | MEC : 03/059 |
| ISRCTN | ISRCTN59497461 |