ISRCTN - ISRCTN76742797: The SPARTAC trial: a multicentre randomised trial of therapeutic intervention at primary human infection immunodeficiency virus-1 (HIV-1) infection

Plain English Summary

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

Trial website

http://www.imperial.ac.uk/departmentofmedicine/divisions/infectiousdiseases/infectious_diseases/hiv_trials/hiv_treatment/spartac

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 type

University/education

Website

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data