Treataware

Browse the clinical trials database - closed trials

Closed clinical trials in the NAPWA database are listed below – the most recently-added entries are shown at the top of the list.

(‘Closed’ clinical trials include those listed as fully enrolled, concluded, or cancelled.)

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.

STEP HIV vaccine study

Cancelled | vaccine | Last update: 13 Nov 2008
Entry status: 
preventative
prophylactic
safe sex
vaccine
Complete, approved
randomised
proof-of-concept
placebo controlled
phase II
multicentre
double-blind
Keywords: 
preventative
prophylactic
safe sex
vaccine
Design keywords: 
randomised
proof-of-concept
placebo controlled
phase II
multicentre
double-blind

This is a study of a vaccine with the potential to prevent HIV infection. Unlike other studies listed on this site it is only open to people who are HIV negative.

This is an early-stage study. It is not aiming to prove that the vaccine will prevent HIV in large numbers of people, but rather that it (1) is safe and well-tolerated and (2) may provide some evidence that it EITHER reduces the number of people who acquire HIV or can prevent people from developing any illness resulting from exposure to HIV.

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.

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.

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)

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.

Nevirapine toxicogenomics study

No longer enrolling | se_management | Last update: 8 Jul 2008
Entry status: 
phase IV
open-label
multicentre
international
Complete, approved
side effects and toxicities
nevirapine
liver
hepatotoxicity
genetics
Keywords: 
side effects and toxicities
nevirapine
liver
hepatotoxicity
genetics
Design keywords: 
phase IV
open-label
multicentre
international

This study is looking for people who take or have taken nevirapine as part of their drug regimen. The study wants to see if there are any genetic differences which may help predict who is likely to react badly to the drug.

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.

Rollover Tipranavir and Ritonavir Trial

Fully enrolled | tx_strategy | Last update: 8 Jul 2008
Entry status: 
rollover study
phase II
open-label
multicentre
international
Complete, approved
tipranavir
ritonavir
optimised background regimens
fixed-dose combinations
Keywords: 
tipranavir
ritonavir
optimised background regimens
fixed-dose combinations
Design keywords: 
rollover study
phase II
open-label
multicentre
international

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.

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.

ESPRIT (IL-2)

Fully enrolled | immune_based_tx | Last update: 8 Jul 2008
Entry status: 
randomised
open-label
Complete, approved
interleukin-2
immune-based therapies
cytokines
Keywords: 
interleukin-2
immune-based therapies
cytokines
Design keywords: 
randomised
open-label

This study compares people who are taking interleukin-2 (IL-2) along with their antiretrovirals with those who are not. The intention is to show whether or not the CD4 cells which are 'regained' after stimulating the immune system with IL-2 are actually good, functional CD4 cells capable of assisting in protecting against HIV-related immunodeficiency and AIDS.

STALWART: Interleukin-2 with and without antiretroviral therapy

No longer enrolling | immune_based_tx | Last update: 8 Jul 2008
Entry status: 
randomised
prospective
phase II
open-label
international
Complete, approved
interleukin-2
immune-based therapies
cytokines
Keywords: 
interleukin-2
immune-based therapies
cytokines
Design keywords: 
randomised
prospective
phase II
open-label
international

This study is looking at the effect that short cycles of interleukin-2 (IL-2) has on viral load and CD4 count when someone is taking antiretrovirals and when someone is not.

Interleukin-2 is a treatment which is administered by injection, twice a day, in treatment 'cycles' lasting for five days.

For the first period of the study, the period between cycles is 6-10 weeks. After that, when and how often people cycle is guided by their CD4 count.

NGX-4010 (neuropathy treatment)

Reported | se_management | Last update: 3 Jul 2008
Entry status: 
randomised
placebo controlled
phase III
double-blind
Complete, approved
side effects and toxicities
peripheral neuropathy
NGX-4010
neuropathy
capsaicin
Keywords: 
side effects and toxicities
peripheral neuropathy
NGX-4010
neuropathy
capsaicin
Design keywords: 
randomised
placebo controlled
phase III
double-blind

This trial will evaluate whether an experimental drug (NGX-4010) is both safe to use and an effective treatment for the pain resulting from HIV-associated neuropathy.

The study drug contains capsaicin - a substance found in chilli peppers - and is applied to the skin as a patch.

This is a randomised study where people receive either a low concentration patch (acting as placebo) or a high concentration patch for a period of 30 or 60 minutes.

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.

MK0518 (raltegravir) versus Kaletra - studies A and B

No longer enrolling | new_drug | Last update: 30 Jun 2008
Entry status: 
randomised
phase III
multicentre
double-blind
Complete, approved
ritonavir
raltegravir
lopinavir
Keywords: 
ritonavir
raltegravir
lopinavir
Design keywords: 
randomised
phase III
multicentre
double-blind

The purpose of these studies is to investigate the efficacy, safety, and tolerability of raltegravir - a new drug from the new class of integrase inhibitors. These studies will compare a raltegravir-based regimen with a lopinavir-based one.

FLASH (lipoatrophy)

Reported | se_management | Last update: 26 Jun 2008
Entry status: 
randomised
prospective
phase IV
open-label
multicentre
Complete, approved
side effects and toxicities
polylactic acid
plastic surgery
lipoatrophy
facial wasting
Keywords: 
side effects and toxicities
polylactic acid
plastic surgery
lipoatrophy
facial wasting
Design keywords: 
randomised
prospective
phase IV
open-label
multicentre

The FLASH study was designed to assess treatment with polylactic acid for facial fat loss - a condition called lipoatrophy associated with taking HIV drugs

Polylactic acid (marketed as Sculptra and also formerly known as New-Fill) is a substance which is injected into areas of the face affected by fat wasting. Participants in the trial were randomly assigned to receive the treatment immediately or after a six-month delay

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.

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.

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.

SPARTAC (early intervention)

Fully enrolled | tx_strategy | Last update: 24 Jun 2008
Entry status: 
randomised
prospective
multicentre
Complete, approved
starting treatment
newly HIV positive
Keywords: 
starting treatment
newly HIV positive
Design keywords: 
randomised
prospective
multicentre

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.

BITE (nutritional supplement)

No longer enrolling | nutritional_supplement | Last update: 24 Jun 2008
Entry status: 
randomised
prospective
placebo controlled
Complete, approved
nutrition
Keywords: 
nutrition
Design keywords: 
randomised
prospective
placebo controlled

This is a trial of a food supplement(NR100157) in people who do not currently take HIV antiretroviral treatment. The trial will assess whether the supplement, which contains a combination of special proteins, fats, vitamins, minerals and fibres, has a beneficial effect on the immune system

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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.