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SPARTAC
SPARTAC is an international randomised-controlled trial comparing 3 different strategies of intervention in patients recently infected with HIV, referred to as Primary HIV Infection (PHI).
The main objective is to
determine whether being treated at primary HIV infection for a limited duration
delays damage to the immune system and consequently prolongs time to initiation
of long-term anti-retroviral therapy.
The primary outcome measure will be time for CD4 cell count to drop below
350 cells/µl on 2 consecutive occasions or starting late anti-HIV
treatment administered according to local HIV treatment guidelines. We will
also be looking at the effect of primary HIV treatment on disease progression
and the development of AIDS events.
Patients are eligible if
they have reached the age of consent and are confirmed Primary HIV Infection
by at least one of the following criteria:
1. HIV positive antibody test within 6 months of an HIV negative antibody
test
2. HIV antibody negative with positive RT-PCR
3. Test “incident” at low level (<0.6) using detuned assay
(must be subtype B)
4. Equivocal HIV antibody test supported by a repeat test within a 2-week
period showing a rising optical density
5. Have clinical manifestations of symptomatic HIV seroconversion illness
supported by antigen positivitiy and <4 bands positive on Western Blot
Patients will be randomised
into one of three arms:
A. Long Course combination Anti-retroviral Therapy (LCART) for 48 weeks.
B. Short Course combination Anti-retroviral Therapy (SCART) for 12 weeks.
C. No Anti-retroviral Therapy
The recommended regimen is Combivir and Kaletra, although other drugs will
be allowed. Following this intervention at primary HIV infection, all patients
will cease treatment and will be followed according to the trial schedule.
If disease progression necessitates treatment, anti-retroviral drugs will
be introduced according to the local standards of care.
SPARTAC is currently
recruiting from the Australia (12 sites), Brazil (1 site), Ireland (1 site),
Italy (1 site), South Africa (10 sites), UK (9 sites) and Uganda (1 site).
The sites in Brazil, Ireland, Italy, UK, South Africa and Uganda are being
co-ordinated by MRC CTU; the sites in Australia are being co-ordinated by
NCHECR.
Abbott is supplying Kaletra to sites in South Africa.
| Accrual target: |
360 |
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| Accrual count: |
199 |
as of: |
5 August
2006 |
Recruitment began in
November 2004 and will continue until April 2007. The total duration of
the trial is expected to be 5 years.
| Funding Body |
Wellcome Trust |
| Chief Investigator(s) |
Prof. Jonathan
Weber, Imperial College London
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N.B. Please note that the information presented on this
page may have changed since
the page was last updated on:
04/08/2006
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©2004 MRC Clinical Trials Unit |
