Treataware

Trials where the study type is 'SE_MANAGEMENT'

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

Predictors of drug hypersensitivity

Enrolling | se_management | Last update: 24 Jun 2008
Entry status: 
observational
case-control
Complete, approved
nevirapine
hypersensitivity
efavirenz
abacavir
Keywords: 
nevirapine
hypersensitivity
efavirenz
abacavir
Design keywords: 
observational
case-control

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.

Abacavir hypersensitivity study

Reported | se_management | Last update: 24 Jun 2008
Entry status: 
observational
Complete, approved
hypersensitivity
HLA-B*5701
abacavir
Keywords: 
hypersensitivity
HLA-B*5701
abacavir
Design keywords: 
observational

This is an observational study looking at a particular genetic sequence sometimes found in the immune system which is directly associated with the risk of developing a hypersensitivity reaction (a severe, sometimes life-threatening reaction) to the HIV antiretroviral drug abacavir. The genetic sequence associated with this problem is known as HLA-*B5701 and it is present in a small percentage of the population. It is this percentage of people who are at risk of a severe reaction when they start abacavir, so it is not used in people who have this genetic trait.

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.

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.

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.

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.

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This information was retrieved from the Treataware website (www.treataware.info) on 5 Dec 2008. For further information, please consult the website or call the NAPWA office on 02 8568 0300.