An international study to test whether a short period of treatment in the early stages of HIV infection can delay the need for antiretroviral treatment is likely to begin recruitment in South Africa, Italy, France and Denmark shortly. The study is already recruiting in the United Kingdom, Ireland and Australia, and is coordinated by the UK’s Medical Research Council Clinical Trials Unit.
The trial is called Spartac (Short Pulse AntiRetroviral Therapy At HIV seroConversion). It is recruiting people with primary HIV infection and randomising them to one of three regimens:
- Long course combination antiretroviral therapy (LCART) for 48 weeks
- Short course combination antiretroviral therapy (SCART) for 12 weeks
- No antiretroviral therapy
The choice of drugs will be left to the individual participant and their treating physician.
At present the potential effect of HAART soon after infection on the subsequent course of HIV disease is unknown, and Spartac is the first randomised study to test the approach.
The main outcome that will be monitored in the study is the time it takes patients to reach a CD4 cell count below 350/mm3. This threshold has been chosen because it represents the CD4 cell count at which patients would normally be advised to begin considering the possibility of antiretroviral treatment if they have high viral load and a rapidly declining CD4 cell count, according to current UK and US guidelines.
Patients will be eligible to join the study if they have a positive HIV antibody test result less than six months after a negative antibody test. Several other laboratory markers of HIV infection could also make people eligible to join the study:
- HIV antibody negative with positive RT-PCR (viral load)
- Test “incident” at low level (
- Equivocal HIV antibody test supported by a repeat test within a 2-week period showing a rising optical density
- Clinical manifestations of symptomatic HIV seroconversion illness supported by antigen positivity and
“We've purposefully not restricted the trial to acute HIV infection so that results can be applicable to a wider group of HIV-positive people than the handful of acutely infected individuals a clinician may see in a blue moon,” Dr Sarah Fidler, Trial Physician from Imperial College London, told aidsmap.com. “This was also the rationale for including diagnosis of recent infection through the detuned assay as this could be readily used in all newly diagnosed HIV-infected individuals.”