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 |
| EudraCT/CTIS number | 2004-000446-20 |
| Secondary identifying numbers | 069598 |
- 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
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=32
Contact information
Prof Jonathan Weber
Scientific
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 |
|---|---|
| j.weber@imperial.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact clinical.researchoffice@imperial.ac.uk to request a patient 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 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(s) | The London Multicentre Research Ethics Committee (MREC), 29/07/2004, ref: 04/2/025 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/11/2004 |
| Overall study end date | 30/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 360 |
| 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 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
- England
- United Kingdom
Study participating centre
Imperial College of Sci Tech & Med
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
Level 2, Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
England
United Kingdom
| clinical.researchoffice@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
