SPARTAC stands for Short Pulse AntiRetroviral Therapy At seroConversion and the trial compares two different durations of treatment for people who have been very recently infected with HIV. These are compared to a third group of recent seroconverters who remain off treatment altogether.
The trial will compare how each approach affects the immune system. If the immune system can be protected from HIV by treating it for a short period soon after becoming infected, it may be possible to delay the need for ongoing long-term treatment.
This is a randomised study which compares three different possible starting combinations of antiretriovirals. Everyone in the study will receive a fixed-dose combination pill containing tenofovir plus emtricitabine (Truvada) with either efavirenz, atazanavir/r (the small 'r' means with a low dose of ritonavir) or AZT plus abacavir.
Each group will be compared to see which combinations are easy to take, which ones carry side effects and which ones are most effective against HIV.
We don't know why antiretroviral treatment can suppress some people's viral load but not give them a good T cell count.
This study will test two theories:
The first is that even a low level of viral activity prevents some people from rebuilding their immune system and therefore they need a stronger treatment regimen, in this case one boosted with the new integrase inhibitor - raltegravir.
This study is testing a combination of tipranavir and ritonavir to see how safe and easy-to-take the drugs are together.
The idea is to combine the two drugs into one pill or 'fixed dose combination' containing 500mg of tipranavir and 200mg of ritonavir which can be taken twice a day along with an optimized background regimen.
This study is looking at two versions of the same drug - nevirapine - and comparing the effectiveness and safety of one that releases the drug over a long period against one that does so immediately.
It's a double-blind/double-dummy trial so no-one knows who's on which version of the drug - the slow release one or the immediate release one. Everyone will be put on the same background regimen - Truvada (tenofovir-emtracitabine).
You need to be treatment naive to enrol.
It is desirable to obtain extended follow up data on subjects who participated in the 2NN study and the CHARM study in order to see if the beneficial effect of using nevirapine continues up to 144 weeks of treatment.
This study is testing whether taking 800mg of darunavir once-a-day is as effective as taking 600mg of darunavir twice-a-day. (Both doses will be boosted with 100mg of ritonavir).
Participants will also take an individually selected optimised background regimen. This trial is looking for people who are currently on treatments.
A treatment regimen consisting of one non-nucleoside (1NNRTI) and two nucleosides (2NRTIs) has become the internationally accepted first-line therapy of choice. But affective as the combination is, it doesn't work for everyone. And those it fails need a reliable back-up. At the moment there is no "internationally accepted" second-line.
A treatment regimen containing one protease inhibitor (PI) and two nucleoside/nucleotide reverse transcriptase inhibitors ('nucleosides' or NRTIs) is standard practice these days. While this 'PI+2NRTI' combination is very good at suppressing the virus it can also cause some major side effects. Significantly, PIs have been associated with cardiovascular disease (heart attack) and NRTIs with mitochondrial toxicity (see background info).
The purpose of this study is to see if giving antiretrovirals to people soon after they have been infected with HIV can help them control HIV. The study will also see if the immune system can control the amount of HIV virus in the blood (viral load) even after a person has stopped taking the medications. The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patient's immune system to control HIV viral load.
This information was retrieved from the Treataware website (www.treataware.info) on 19 Nov 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.