Open clinical trials in the NAPWA database are listed below – the most recently-added entries are shown at the top of the list.
(‘Open’ clinical trials are those listed as enrolling now or not yet started.)
These two trials are for people who have never taken any anti-HIV drugs in the past.
They are both comparing the effectiveness, safety and tolerability of rilpivirine (TMC278) - a new Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)- against efavirenz - another NNRTI.
One trial stipulates the use of tenofovir/emtricitabine(FTC) as the background regimen.
The other trial gives you the choice of background regimen from these combinations: abacavir/lamivudine(3TC), tenofovir/emtricitabine(FTC) or zidovudine(AZT)/lamivudine(3TC).
This study is looking at the safety, tolerability and efficacy of elvitegravir, a new protease inhibitor, boosted with ritonavir.
They are comparing the drug to the newly approved integrase inhibitor - raltegravir.
People who are treatment experienced will be given either drug with a background regimen including another protease inhibitor.
This is an observational study, looking at the effect HIV treatment has on the health of our heart. The investigators are comparing how well cholesterol is processed by those not on therapy with those who are on treatment. They are also comparing those on NNRTI-based regimens with those on PI- based ones.
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 is a trial for a new antiretroviral called apricitabine - an experimental nucleoside reverse transcriptase inhibitor for people who are resistant to other NRTIs, and who have the M184V mutation.
This study will look at how safe, easy to take and effective apricitabine is in people who are resistant to 3TC. If successful, it is hoped to use it as an alternative.
This trial is providing people who have limited treatment options open to them access to maraviroc until it offically becomes available. In the process, the trial will collect more safety data on the drug.
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.
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).
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.
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 will compare the effect of the new integrase inhibitor, raltegravir, with that of low-dose ritonavir on triglyceride and lipid (fat) levels. Volunteers who don't have HIV will be given either 100mg of ritonavir once a day or 400mg of raltegravir twice a day for 4 weeks.
This trial is providing access to an experimental non-nucleoside (NNRTI) called etravirine for people who did not reach undetectable viral load levels on either of the prior DUET studies.
The study will look at the long-term safety and tolerability of etravirine as part of an optimised background regimen including darunavir and other drugs chosen by their doctor.
All people will receive etravirine until the drug is approved and commercially available.
This study will compare people who are hypersensitive to three particular drugs with people who are not. The three drugs - nevirapine, efavirenz and abacavir - are all known to cause hypersensitivity reactions in a small number of people and so the study is looking for particular immune system markers which might predict who can safely take them and who might have reactions to them.
This is an observational study. There is no experimental treatment associated with this trial.
This study will investigate the impact hepatitis B has on liver disease in people who also have HIV and are currently on HIV treatments. It will also monitor to see if anyone develops any resistance to their HIV treatments because of their hepatitis B.
It involves six-monthly visits and physical examinations to track your health progression over five years
The aim of the study is to identify any changes in the HBV DNA that might be associated with resistance to tenofovir, to determine how long any changes take to occur and the effect of these changes on the clinical response to tenofovir.
This study is looking at how our immune system functions when we are coinfected with both HIV and either hepatitis B or C.
It might show us how some people can clear hepatitis from their system when they're on treatment while others can when they're not.
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.
This information was retrieved from the Treataware website (www.treataware.info) on 20 Nov 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.