Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dr. J.M. Prins

ORCID ID

Contact details

Academic Medical Centre (AMC)
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 4380
j.m.prins@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR101

Study information

Scientific title

Acronym

Primo-SHM

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.

As of 10/08/2010 this record was updated with protocol amendments; at this time, the anticipated end date of this trial was extended to 1st February 2012, the initial anticipated end date of this trial was 1st May 2006. At this time, the target number of participants was also increased from 60 to 173.

Ethics approval

Approval received from the AMC Medical Ethics Committee (ref: MEC 03/059).

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Highly active anti-retroviral therapy (HAART)

Primary outcome measures

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 measures

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

Overall trial start date

01/05/2003

Overall trial end date

01/02/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

173

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/05/2003

Recruitment end date

01/02/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Government

Funder name

Dutch Government (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes