Treataware

Trials where the study type is 'EXISTING_DRUG'

STEAL (fixed-dose combinations)

Fully enrolled | existing_drug | Last update: 8 Jul 2008
Entry status: 
randomised
open-label
multicentre
Complete, approved
tenofovir
lamivudine
fixed-dose combinations
emtricitabine
abacavir
Keywords: 
tenofovir
lamivudine
fixed-dose combinations
emtricitabine
abacavir
Design keywords: 
randomised
open-label
multicentre

The STEAL study is comparing two different 'fixed-dose combination' treatments. These are: abacavir combined with lamivudine - marketed in Australia as Kivexa -and tenofovir combined with emtricitabine  - marketed as Truvada.

Both treatments are taken in combination with other antiretrovirals from different classes. The study will compare the pills for safety and for effectiveness against HIV.

The study is due for completion in August 2008.

TITAN (darunavir)

Reported | existing_drug | Last update: 26 Jun 2008
Entry status: 
prospective
open-label
Complete, approved
TMC114
Special Assistance Schemes
rollover study
ritonavir
protease inhibitors
darunavir
boosted PIs
Keywords: 
TMC114
Special Assistance Schemes
rollover study
ritonavir
protease inhibitors
darunavir
boosted PIs
Design keywords: 
prospective
open-label

This study compares darunavir/r to lopinavir/r (the 'r' signifies that a small dose of ritonavir is also used) in people who are treatment experienced.

The study will compare these two approaches for their safety and tolerability, as well as their effectiveness in fighting HIV.

ARTEMIS (darunavir)

Reported | existing_drug | Last update: 26 Jun 2008
Entry status: 
randomised
prospective
Complete, approved
TMC114
ritonavir
protease inhibitors
lopinavir
boosted PIs
Keywords: 
TMC114
ritonavir
protease inhibitors
lopinavir
boosted PIs
Design keywords: 
randomised
prospective

This study is comparing darunavir boosted with low-dose ritonavir (TMC 114/r) with lopinavir boosted with low-dose ritonavir (Kaletra) in people who have never taken any antiretroviral treatment before. All people on the study will also be treated using the fixed-dose combination of tenofovir combined with emtricitabine (Truvada).

The two approaches will be compared for safety, tolerability and effectiveness in fighting HIV.

HIV/HBV coinfection and tenofovir resistance

Enrolling | existing_drug | Last update: 19 Jun 2008
Entry status: 
observational
Complete, approved
tenofovir
hepatitis B
coinfection
Keywords: 
tenofovir
hepatitis B
coinfection
Design keywords: 
observational

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.  

BLQ study (darunavir plus enfuvirtide)

Reported | existing_drug | Last update: 19 Jun 2008
Entry status: 
phase IV
open-label
Complete, approved
protease inhibitors
optimised background regimens
enfuvirtide
darunavir
Keywords: 
protease inhibitors
optimised background regimens
enfuvirtide
darunavir
Design keywords: 
phase IV
open-label

This study looked at the new protease inhibitor (PI) darunavir and how safe, effective and easy-to-take it is with an 'optimised background regimen' including enfuvirtide (T-20).

The trial enrolled people who had been on triple-class therapy before but had never had enfuvirtide or darunavir.

RESIST (tipranavir)

No longer enrolling | existing_drug | Last update: 8 Jul 2008
Entry status: 
randomised
phase III
open-label
multicentre
international
Complete, approved
tipranavir
ritonavir
Keywords: 
tipranavir
ritonavir
Design keywords: 
randomised
phase III
open-label
multicentre
international

This study is looking at how safe and effective tipranavir is (with low-dose ritonavir) compared to other protease inhibitor-based regimens in people who are highly treatment experienced.

CASTLE (atazanavir versus lopinavir)

Fully enrolled | existing_drug | Last update: 19 Jun 2008
Entry status: 
randomised
phase III
open-label
Complete, approved
tenofovir
ritonavir
emtricitabine
BMS-232632
atazanavir
Keywords: 
tenofovir
ritonavir
emtricitabine
BMS-232632
atazanavir
Design keywords: 
randomised
phase III
open-label

This trial is looking at how safe, easy-to-take and effective a combination containing atazanavir/r is compared to one containing lopinavir/r.

The other antiretrovirals taken by both arms of the study are tenofovir and emtricitabine given in a fixed-dose combination pill marketed as Truvada.

TEddI (adherence)

Reported | existing_drug | Last update: 19 Jun 2008
Entry status: 
randomised
phase IV
open-label
multicentre
Complete, approved
lamivudine
efavirenz
didanosine
adherence
Keywords: 
lamivudine
efavirenz
didanosine
adherence
Design keywords: 
randomised
phase IV
open-label
multicentre

We know that adherence is important for treatment success, so this study compares a once-a-day regimen with a twice-a-day one.

HIV/HBV coinfection and tenofovir (TICO)

Reported | existing_drug | Last update: 22 Sep 2008
Entry status: 
tenofovir
Keywords: 
tenofovir

The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)

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 22 Nov 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.