Treataware

Trials where the study type is 'NEW_DRUG'

Uridine and/or pravastatin for treating lipoatrophy

Fully enrolled | new_drug | Last update: 26 Jun 2008
Entry status: 
randomised
phase IV
Complete, approved
zidovudine
uridine
stavudine
ritonavir
pravastatin
lopinavir
lipoatrophy
facial wasting
Keywords: 
zidovudine
uridine
stavudine
ritonavir
pravastatin
lopinavir
lipoatrophy
facial wasting
Design keywords: 
randomised
phase IV

This study is looking at two products, uridine and pravastatin, to see if they can help with lipoatrophy (the loss of fat from cheeks, limbs and buttocks). Over 28 weeks, the study will compare people who are being treated with one, both or neither of the products to see if there are any changes. The study will also monitor any side effects to see whether the products are safe.

Merck Integrase Inhibitor Study (raltegravir)

Fully enrolled | new_drug | Last update: 30 Jun 2008
Entry status: 
randomised
prospective
placebo controlled
phase III
multicentre
international
double-blind
Complete, approved
raltegravir
nucleosides
non-nucleosides
multiple resistance
integrase inhibitors
Keywords: 
raltegravir
nucleosides
non-nucleosides
multiple resistance
integrase inhibitors
Design keywords: 
randomised
international
placebo controlled
prospective
double-blind
multicentre
phase III

This is the Phase III study of raltegravir - from the new drug class of integrase inhibitors which are designed to attack HIV in a different way to the other classes currently available on the Australian market.

The study compares an optimised background therapy used with and without raltegravir. Comparing results will allow the researchers to look at whether the addition of an integrase inhibitor is more effective against HIV than using the current drugs alone.

TMC125 (etravirine) for people who failed on the DUET studies

Enrolling | new_drug | Last update: 26 Jun 2008
Entry status: 
prospective
phase III
open-label
Complete, approved
TMC125
TMC114
multiple resistance
etravirine
darunavir
Keywords: 
TMC125
TMC114
multiple resistance
etravirine
darunavir
Design keywords: 
prospective
phase III
open-label

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.

POWER-3 STUDY (darunavir)

Concluded | new_drug | Last update: 24 Jun 2008
Entry status: 
rollover study
Complete, approved
TMC114
Special Assistance Schemes
rollover study
protease inhibitors
darunavir
Keywords: 
TMC114
Special Assistance Schemes
rollover study
protease inhibitors
darunavir
Design keywords: 
rollover study

This was a rollover study, to provide darunavir for people who participated in one of two previous clinical trials before it was approved.

DUET study (etravirine)

Reported | new_drug | Last update: 24 Jun 2008
Entry status: 
randomised
placebo controlled
phase III
double-blind
Complete, approved
TMC125
optimised background regimens
non-nucleosides
Keywords: 
TMC125
optimised background regimens
non-nucleosides
Design keywords: 
randomised
placebo controlled
phase III
double-blind

Etravirine (TMC 125) is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI). This trial is to study the safety and tolerability of this treatment, and its effectiveness against HIV.

The trial is randomised and people take either etravirine in combination with an optimized background regimen or a combination without etravirine.

AVX-201E (apricitabine) extension study

Fully enrolled | new_drug | Last update: 24 Jul 2008
Entry status: 
rollover study
prospective
open-label
Complete, approved
nucleosides
apricitabine
Keywords: 
nucleosides
apricitabine
Design keywords: 
rollover study
prospective
open-label

This is an extension study of a Phase II trial for a new treatment called apricitabine. It is basically a study which allows ongoing access to this treatment for people who were involved in the Phase II study.

CCR5 inhibitor trial: maraviroc (treatment-naive)

No longer enrolling | new_drug | Last update: 21 Jul 2008
Entry status: 
randomised
prospective
phase III
Complete, approved
zidovudine
maraviroc
lamivudine
entry inhibitors
efavirenz
chemokines
CCR5
Keywords: 
zidovudine
maraviroc
lamivudine
entry inhibitors
efavirenz
chemokines
CCR5
Design keywords: 
randomised
prospective
phase III

This is an ongoing Phase III trial of an HIV antiretroviral from a new class of drugs, known as 'entry inhibitors'. Entry inhibitors work by trying to prevent HIV from attaching to or being able to enter and infect cells.

CCR5 inhibitor trial: maraviroc (treatment experienced)

Reported | new_drug | Last update: 24 Jun 2008
Entry status: 
randomised
prospective
phase III
Complete, approved
resistance testing
optimised background regimens
maraviroc
entry inhibitors
CCR5
Keywords: 
resistance testing
optimised background regimens
maraviroc
entry inhibitors
CCR5
Design keywords: 
randomised
prospective
phase III

This is an ongoing trial of an experimental HIV antiviral from a new class of drugs, known as 'entry inhibitors'. Entry inhibitors work by trying to prevent HIV from attaching to or being able to enter and infect cells.

The drug in this trial, maraviroc, is called a CCR5 inhibitor, and is designed to prevent HIV from attaching to specific 'receptors' on the surface of human immune cells. If HIV can't attach to the cell, it can't infect it (see Background Info for more discussion). The particular cell 'marker' which HIV uses to attach to a cell is called CCR5.

PINT (including raltegravir)

Fully enrolled | new_drug | Last update: 28 Oct 2008
Entry status: 
raltegravir
tenofovir
Truvada
Complete, approved
open-label
Keywords: 
raltegravir
tenofovir
Truvada
Design keywords: 
open-label

The purpose of this study is to measure how well HIV is controlled in the blood of patients taking a regimen including raltegravir - a drug from the new class of integrase inhibitors.

AVX-301 (apricitabine)

Enrolling | new_drug | Last update: 24 Jul 2008
Entry status: 
randomised
phase III
phase II
multicentre
international
double-blind
Complete, approved
lamivudine
apricitabine
Keywords: 
lamivudine
apricitabine
Design keywords: 
randomised
phase III
phase II
multicentre
international
double-blind

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.

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This information was retrieved from the Treataware website (www.treataware.info) on 21 Nov 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.