Contact information
Type
Scientific
Primary contact
Prof Jonathan Weber
ORCID ID
Contact details
Imperial College of Sci Tech & Med
Medical School
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3905
j.weber@imperial.ac.uk
Additional identifiers
EudraCT number
2004-000446-20
ClinicalTrials.gov number
Protocol/serial number
069598
Study information
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
Acronym
SPARTAC
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.
Ethics approval
The London Multicentre Research Ethics Committee (MREC), 29/07/2004, ref: 04/2/025
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact clinical.researchoffice@imperial.ac.uk to request a patient information sheet
Condition
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 names
Primary outcome measure
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 measures
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
Overall trial start date
01/11/2004
Overall trial end date
30/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
360
Participant 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
Recruitment start date
01/11/2004
Recruitment end date
30/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College of Sci Tech & Med
London
W2 1PG
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Level 2
Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
United Kingdom
-
clinical.researchoffice@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23323897
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24205183
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24549145
Publication citations
-
Results
, Fidler S, Porter K, Ewings F, Frater J, Ramjee G, Cooper D, Rees H, Fisher M, Schechter M, Kaleebu P, Tambussi G, Kinloch S, Miro JM, Kelleher A, McClure M, Kaye S, Gabriel M, Phillips R, Weber J, Babiker A, Short-course antiretroviral therapy in primary HIV infection., N. Engl. J. Med., 2013, 368, 3, 207-217, doi: 10.1056/NEJMoa1110039.
-
Results
Frater J, Ewings F, Hurst J, Brown H, Robinson N, Fidler S, Babiker A, Weber J, Porter K, Phillips RE, HIV-1-specific CD4+ responses in primary HIV-1 infection predict disease progression., AIDS, 2014, 28, 5, 699-708, doi: 10.1097/QAD.0000000000000130.
-
Results
Stöhr W, Fidler S, McClure M, Weber J, Cooper D, Ramjee G, Kaleebu P, Tambussi G, Schechter M, Babiker A, Phillips RE, Porter K, Frater J, Duration of HIV-1 viral suppression on cessation of antiretroviral therapy in primary infection correlates with time on therapy, PLoS One, 2013 , 8, 10, e78287, doi: 10.1371/journal.pone.0078287.