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The SPARTAC Trial: a multicentre randomised trial of therapeutic intervention at primary human infection immunodeficiency virus-1 (HIV-1) infection
DOI 10.1186/ISRCTN76742797
ClinicalTrials.gov identifier
EudraCT number 2004-000446-20
Public title The SPARTAC Trial: a multicentre randomised trial of therapeutic intervention at primary human infection immunodeficiency virus-1 (HIV-1) infection
Scientific title Short Pulse AntiRetroviral Therapy At human infection immunodeficiency virus (HIV) seroConversion: a Multicentre randomised trial of therapeutic intervention at primary HIV-1 infection
Serial number at source 069598
Study hypothesis The study is a randomised controlled trial comparing three different strategies of intervention in Primary Human Immunodeficiency Virus (HIV) Infection (PHI). The primary objective is to determine the effect of two anti-HIV treatment schedules of limited duration in PHI on the rate of CD4 decline and, consequently, on the time to initiating long-term anti-HIV therapy. The secondary objective is to evaluate the effect of different durations of treatment during PHI on HIV-specific immune response and disease progression. The aim of early antiretroviral intervention is to preserve HIV-specific CD4+ T-cell responses from HIV-induced lysis in order to confer enhanced control of viral replication when therapy is subsequently discontinued.
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=32
Ethics approval Added 23/02/2009: The London Multicentre Research Ethics Committee (MREC) on 29/07/2004 (ref: 04/2/025)
Study design Multicentre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Human immunodeficiency virus (HIV)
Participants - inclusion criteria Patients of both sexes will be eligible for screening if they:
1. Have reached the age of consent in their country for participating in a clinical study
2. Are confirmed PHI by at least one of following criteria:
a. HIV positive antibody test within six-months of an HIV negative antibody test (randomisation must take place within six months of previous negative test)
b. HIV antibody negative with positive Reverse Transcription Polymerase Chain Reaction (RT-PCR)
c. Test 'incident' at low level (less than 0.6) using detuned assay (must be subtype B)
d. Equivocal HIV antibody test supported by a repeat test within a two-week period showing a rising optical density
e. Have clinical manifestations of symptomatic HIV seroconversion illness supported by antigen positivity and less than four bands positive on Western Blot
3. Able and willing to give written informed consent
Participants - exclusion criteria Patients will not be eligible for screening if:
1. Pregnant
2. Unlikely to comply with protocol, and in particular adhere to therapeutic regimen
3. Likely to use narcotics during the study period
4. Antiretroviral therapy is indicated
5. Antiretroviral therapy is contraindicated
Anticipated start date 01/11/2004
Anticipated end date 30/01/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact clinical.researchoffice@imperial.ac.uk to request a patient information sheet
Target number of participants 360 - recruitment will close on the 30th May 2007
Interventions Participants will be randomly allocated in a 1:1:1 ratio at trial entry to start one of the regimens of open treatment with:
Arm A: Long course Combination AntiRetroviral Therapy (LCART) for 48 weeks
Arm B: Short course Combination AntiRetroviral Therapy (SCART) for 12 weeks
Arm C: No antiretroviral therapy

The regimen should be started, ideally, on the day of randomisation, or within 72 hours.
Primary outcome measure(s) Time to CD4 cell count less than 350 cells/l (excluding counts in the first three months after diagnosis) on two consecutive occasions not more than four weeks apart. Intervention at PHI is termed PTX (primary treatment) to distinguish it from late treatment (LTX), which may be administered according to local HIV treatment guidelines when indicated.
Secondary outcome measure(s) 1. HIV-specific CD4+ and CD8+ T-cell responses at week 60
2. Slope of CD4 decline
3. Time from randomisation to virological failure of first regimen of late treatment (LTX) or death
4. Development of drug resistance not present at baseline, before starting LTX or at week 120 whichever is earlier
5. Development of an AutoImmune Deficiency Syndrome (AIDS) defining illness or death
6. Time from randomisation to the initiation of late treatment (LTX)
7. Differences in blood pressure from randomisation at week 12 and week 48
Sources of funding The Wellcome Trust (UK) (grant ref: 069598)
Trial website http://www.imperial.ac.uk/departmentofmedicine/divisions/infectiousdiseases/infectious_diseases/hiv_trials/hiv_treatment/spartac
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23323897
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24549145
Contact name Prof  Jonathan  Weber
  Address Imperial College of Sci Tech & Med
Medical School
Wright-Fleming Institute
Norfolk Place
  City/town London
  Zip/Postcode W2 1PG
  Country United Kingdom
  Tel +44 (0)20 7594 3905
  Fax +44 (0)20 7594 3906
  Email j.weber@imperial.ac.uk
Sponsor Imperial College London (UK)
  Address Level 2, Faculty Building
Clinical Research Office
South Kensington campus
  City/town London
  Zip/Postcode SW7 2AZ
  Country United Kingdom
  Email clinical.researchoffice@imperial.ac.uk
Date applied 22/07/2005
Last edited 24/02/2014
Date ISRCTN assigned 22/07/2005
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