Treataware

Browse the clinical trials database

Clinical trials in the NAPWA database are listed below - the most recently-added entries are shown at the top of the list. Click the trial name for more information about that trial.

The SMART Study

Cancelled | tx_strategy | Last update: 18 Nov 2008
Entry status: 
SMART
structured treatment interruptions
Complete, approved
Keywords: 
SMART
structured treatment interruptions

The purpose of this study was to compare two ways of using antretrovirals: (1) continuously treating with them or (2) only treating when T-cells dropped to 250 and then stopping again when they rose to 350.

The hope was that periodic treatment would prove to be just as effective as continuous treatment and would protect people from any long-term toxicities.

Blood Samples for Genetic Studies (SMART)

Fully enrolled | other | Last update: 14 Nov 2008
Entry status: 
SMART
genetics
Complete, approved
observational
Keywords: 
SMART
genetics
Design keywords: 
observational

The purpose of this substudy was to collect blood samples from SMART study participants for use in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data.

This study enrolled individuals who participated in the SMART study. Participants provided one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.

Effects of HAART on Nervous System Function

No longer enrolling | se_management | Last update: 11 Nov 2008
Entry status: 
dementia
neuropathy
Complete, approved
prospective
observational
Keywords: 
dementia
neuropathy
Design keywords: 
prospective
observational

This study is observing the way different treatment strategies affect nerve and brain function.

Elvitegravir versus raltegravir

Enrolling | new_drug | Last update: 11 Nov 2008
Entry status: 
elvitegravir
raltegravir
ritonavir
Complete, approved
randomised
phase III
multicentre
double-blind
active control
Keywords: 
elvitegravir
raltegravir
ritonavir
Design keywords: 
randomised
phase III
multicentre
double-blind
active control

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.

TMC278 (rilpivirine) versus efavirenz (2 trials)

Enrolling | new_drug | Last update: 27 Nov 2008
Entry status: 
non-nucleosides
emtricitabine
tenofovir
efavirenz
TMC278
rilpivirine
Complete, approved
randomised
phase III
parallel assessment
double-blind
Keywords: 
non-nucleosides
emtricitabine
tenofovir
efavirenz
TMC278
rilpivirine
Design keywords: 
randomised
phase III
parallel assessment
double-blind

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).

Impact of HIV and Its Treatment on Reverse Cholesterol Transport

Enrolling | se_management | Last update: 11 Nov 2008
Entry status: 
cardiovascular disease
Complete, approved
prospective
observational
cohort
Keywords: 
cardiovascular disease
Design keywords: 
prospective
observational
cohort

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.

SWITCH (to raltegravir)

Not yet started | tx_strategy | Last update: 30 Jun 2008
Entry status: 
randomised
open-label
Complete, approved
side effects and toxicities
raltegravir
protease inhibitors
nucleosides
lipoatrophy
cardiovascular disease
Keywords: 
side effects and toxicities
raltegravir
protease inhibitors
nucleosides
lipoatrophy
cardiovascular disease
Design keywords: 
randomised
open-label

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).

Second line

Not yet started | tx_strategy | Last update: 30 Jun 2008
Entry status: 
randomised
open-label
Complete, approved
raltegravir
protease inhibitors
nucleosides
non-nucleosides
first-line therapy
Keywords: 
raltegravir
protease inhibitors
nucleosides
non-nucleosides
first-line therapy
Design keywords: 
randomised
open-label

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.

Anti-HIV-1 Gene Transfer Product

Concluded | new_drug | Last update: 19 Jun 2008
Entry status: 
randomised
phase II
parallel assessment
double-blind
controlled
Complete, approved
genetics
Keywords: 
genetics
Design keywords: 
randomised
phase II
parallel assessment
double-blind
controlled

This is a phase 2 trial to determine the safety and efficacy of an anti-HIV-1 gene transfer product.

TMC114 (darunavir)

Enrolling | tx_strategy | Last update: 19 Jun 2008
Entry status: 
randomised
phase III
open-label
Complete, approved
ritonavir
optimised background regimens
darunavir
Keywords: 
ritonavir
optimised background regimens
darunavir
Design keywords: 
randomised
phase III
open-label

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.

SCH 532706 (new CCR5 inhibitor)

Reported | new_drug | Last update: 19 Jun 2008
Entry status: 
phase I
open-label
Complete, approved
SCH 532706
CCR5
Keywords: 
SCH 532706
CCR5
Design keywords: 
phase I
open-label

This study is looking at a new drug - SCH 532706 - from the new class of CCR5 inhibitors or antagonists.

SCH 532706 is taken twice daily (with a low dose of ritonavir taken once daily) over 10 days. The purpose is to look at how effective the combination is at suppressing HIV as well as how safe and easy it is to take.

Raltegravir versus ritonavir

Not yet started | new_drug | Last update: 30 Jun 2008
Entry status: 
randomised
phase IV
open-label
Complete, approved
ritonavir
raltegravir
lipids
integrase inhibitors
HIV-negative
Keywords: 
ritonavir
raltegravir
lipids
integrase inhibitors
HIV-negative
Design keywords: 
randomised
phase IV
open-label

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.

Expanded Access Program for Maraviroc at Multiple Centres

Enrolling | new_drug | Last update: 22 Jul 2008
Entry status: 
phase III
open-label
multicentre
Complete, approved
multiple resistance
maraviroc
entry inhibitors
CCR5
Keywords: 
multiple resistance
maraviroc
entry inhibitors
CCR5
Design keywords: 
phase III
open-label
multicentre

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.

ATAHC: Australian trial in acute hepatitis C

Fully enrolled | existing_drug | Last update: 19 Jun 2008
Entry status: 
prospective
phase IV
open-label
Complete, approved
ribavirin
liver
interferon
hepatitis C
coinfection
Keywords: 
ribavirin
liver
interferon
hepatitis C
coinfection
Design keywords: 
prospective
phase IV
open-label

This study is following a large group of people with acute hepatitis C virus (HCV) to examine why some people naturally clear the virus and some don't. It will also monitor how many people become re-infected after clearing HCV and look into why this happened.

Three months into the study, everyone taking part has the option to undergo a six month course of pegylated interferon alfa 2a (plus ribavirin for those coinfected with HIV) as treatment for their hepatitis C. The purpose of this part of the study is to examine whether treatment is effective in clearing HCV.

ESP study (adding T-20)

Cancelled | existing_drug | Last update: 19 Jun 2008
Entry status: 
randomised
phase IV
open-label
Complete, approved
enfuvirtide
Keywords: 
enfuvirtide
Design keywords: 
randomised
phase IV
open-label

This study was going to look at the benefits of adding T-20 to people's existing regimens, but recruitment was too slow so the study has been cancelled. Participants were to be randomized to receive T-20 in addition to their current antiretroviral therapy or to continue their current antiretroviral therapy alone.

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This information was retrieved from the Treataware website (www.treataware.info) on 2 Dec 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.