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

ISRCTN	ISRCTN59497461
DOI	https://doi.org/10.1186/ISRCTN59497461
Protocol serial number	NTR101
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Dutch Government (The Netherlands)

Submission date: 23/02/2007
Registration date: 23/02/2007
Last edited: 31/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dr. J.M. Prins
Scientific

Academic Medical Centre (AMC)
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 4380
Email	j.m.prins@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific 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
Study acronym	Primo-SHM
Study objectives	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(s)	Approval received from the AMC Medical Ethics Committee (ref: MEC 03/059).
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV), primary human immunodeficiency virus-1 (HIV-1) infection
Intervention	Six or 15 months of highly-active anti-retroviral therapy (HAART) initiated during primary HIV-1 infection. As of 11/08/2010 the status of this record is that inclusion to the trial has stopped and follow-up is ongoing.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Highly active anti-retroviral therapy (HAART)
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
Key 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
Completion date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	173
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/05/2003
Date of final enrolment	01/02/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2012	16/01/2019	Yes	No
Other publications	Long-term effect of temporary ART initiated during primary HIV-1 infection on viral persistence	30/07/2025	31/07/2025	Yes	No

Editorial Notes

31/07/2025: Publication reference added.
16/01/2019: Publication reference added.
10/08/2010: This record was updated with protocol amendments; at this time, the overall trial end date was extended to 01/02/2012, the initial overall trial end date was 01/05/2006. At this time, the target number of participants was also increased from 60 to 173.