|
ISRCTN
|
ISRCTN59497461
|
|
ClinicalTrials.gov identifier
|
|
|
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.
|
|
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
|
01/05/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
60
|
|
Interventions
|
Six or 15 months of highly-active anti-retroviral therapy (HAART) initiated during primary HIV-1 infection.
|
|
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) - grant
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
J M A
Lange
|
|
Address
|
Academic Medical Centre (AMC)
P.O. Box 22660
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1100 DD
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)20 566 7868
|
|
Email
|
j.lange@amc.uva.nl
|
|
Sponsor
|
Academic Medical Centre (AMC) (The Netherlands)
|
|
Address
|
P.O. Box 22660
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1100 DD
|
|
Country
|
Netherlands
|
|
Sponsor website:
|
http://www.amc.uva.nl
|
|
Date applied
|
23/02/2007
|
|
Last edited
|
20/10/2008
|
|
Date ISRCTN assigned
|
23/02/2007
|
