The SPARTAC trial: a multicentre randomised trial of therapeutic intervention at primary human infection immunodeficiency virus-1 (HIV-1) infection

ISRCTN	ISRCTN76742797
DOI	https://doi.org/10.1186/ISRCTN76742797
Clinical Trials Information System (CTIS)	2004-000446-20
Protocol serial number	069598
Sponsor	Imperial College London (UK)
Funder	Wellcome Trust

Submission date: 22/07/2005
Registration date: 22/07/2005
Last edited: 24/02/2015

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

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=32

Contact information

Prof Jonathan Weber
Scientific

Imperial College of Sci Tech & Med
Medical School
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom

Phone	+44 (0)20 7594 3905
Email	j.weber@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	SPARTAC
Study objectives	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.
Ethics approval(s)	The London Multicentre Research Ethics Committee (MREC), 29/07/2004, ref: 04/2/025
Health condition(s) or problem(s) studied	Human immunodeficiency virus (HIV)
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
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.
Key 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
Completion date	30/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	360
Key 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: 2.1. HIV positive antibody test within six-months of an HIV negative antibody test (randomisation must take place within six months of previous negative test) 2.2. HIV antibody negative with positive Reverse Transcription Polymerase Chain Reaction (RT-PCR) 2.3. Test 'incident' at low level (less than 0.6) using detuned assay (must be subtype B) 2.4. Equivocal HIV antibody test supported by a repeat test within a two-week period showing a rising optical density 2.5. 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
Key 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
Date of first enrolment	01/11/2004
Date of final enrolment	30/05/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Imperial College of Sci Tech & Med

London
W2 1PG
United Kingdom

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	17/01/2013		Yes	No
Results article	results	25/10/2013		Yes	No
Results article	results	13/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes