ANZCTR search results

A randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects

Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease. Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii) blood drug levels in individuals taking both saquinavir formulations when given with atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir formulation with atazanavir as HIV therapy.

This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.

The study hypothesis is that an annual high dose (500,000 IU) of vitamin D2 will reduce the rate of falls and fracture compared with placebo in older women.

Patients taking beta interferon therapy for multiple sclerosis may develop antibodies to the therapy, called neutralising antibodies. These antibodies can block the action of interferon, reducing its bio-availability for use in the body, thereby reducing its effectiveness as a treatment. This study explores one possible way of reducing the levels of neutralising antibodies in the system by suspending interferon treatment, treating the patient with methylprednisolone to reduce the antibody levels, then restarting interferon therapy by giving AVONEX injections once weekly, and testing to see if the bio-availability or 'effectiveness' of the interferon therapy is restored.

This project is a trial of amisulpride in the treatment of schizophrenia and schizoaffective disorder over a 24-week period. Atypical antipsychotic medications, such as amisulpride, are being used more and more to treat the debilitating effects of psychotic symptoms. The trial will be conducted over a 24-week period. It is expected that 40 patients will be recruited to this project. During the 24 weeks, parameters such as tolerability and safety will be assessed using a number of well validated Extra-Pyramidal Side Effects scales in addition to regular monitoring of vital signs, lab, and ECG results. Efficacy assessments will include the PANSS, CGI scales and an appropriate quality of life scale. Patients will also be administered a battery of neuropsychological tests at baseline and 24 weeks to assess and monitor change in cognitive function. Data will be processed using standard statistical techniques.

The trial will determine the effects of intensive weight-bearing exercise after hip fracture. The outcome variables will be walking speed, quadriceps strength, mobility, balance, activities of daily living and quality of life. The experimental hypothesis is that intensive weight-bearing exercise will produce better mobility, strength, balance and other outcomes with no additional complications (including falls and fall related injuries) than non-weight-bearing exercise at 1 and 4 months after recruitment.

Corneal abrasion or ulceration following trauma is the most common ophthalmological condition which presents to Emergency Departments. The cornea is the clear covering over the iris (coloured part of the eye) which is usually injured by objects hitting the surface of the eye (eg during grinding metal or fingernail scratches). Because of the large number of nerve endings in the cornea, surface damage is generally very painful, especially in the first 24 hours. Despite minor corneal trauma being common, the management remains controversial. There is general agreement that oral analgesics should be recommended and that topical antibiotics should be prescribed, although this has been debated. It has been thought in the past that spasm of the eye muscles around the pupil (dark part of the eye) might add to the pain which people experience after minor corneal trauma. A number of eye drops can paralyse these muscles so that this does not occur. This means that the pupil remains large and cannot alter in size in response to changes in light or attempts to focus. This leads to some light sensitivity and blurring of vision, which also occur anyway when the cornea is injured. Some text books recommend use of pupil dilating drops after corneal injury, but a recent literature review on the topic did not recommend their use because one study found no benefit. A recent survey of emergency physicians in Canada found that now only just over half of them are using dilating drops in this setting. This project aims to determine if homatropine 5% (a strong pupil dilating drop) given every six hours for a twenty-four period is effective in reducing eye pain associated with minor corneal abrasion. A total of 60 patients will be asked to participate in this study. Patients will be recruited by doctors working in the emergency department at Dandenong Hospital. Patients who satisfy the trial entry criteria will be asked to instil either homatropine 5% eye drops or hypromellose 0.5% eye drops (inactive placebo). All patients will be prescribed an antibiotic eye ointment to prevent infection in the affected eye. Patients will also be given paracetamol tablets with direction to take two tablets every six hours when required for pain. The visual analogue scale (VAS) will be used in this study to measure the level of pain in patients with corneal abrasion. Statistical analysis will involve comparing the mean pain scores at 0, 6, 12, 18 and 24 hours to find if there is a clinically significant difference between homatropine 5% and hypromellose (placebo). A reduction in VAS score of more than 20mm is considered clinically significant, so a change of this level would support future homatropine use, while a lesser change would not.

This project is associated with a similar correspondence-based treatment for alcohol misuse. It is a randomised controlled trial in which participants are assigned to standard care by their GP or standard care plus correspondence-based treatment for either alcohol or alcohol and depression. After three months, those in the standard care only group are randomly assigned to one of the two experimental groups. The correspondence-based treatments are based on empirically supported cognitive behaviour therapy and comprise four weekly and four fortnightly letters. The alcohol only treatment covers topics such as motivation enhancement, goal setting, dealing with urges, planning for high risk situations, problem solving and relapse prevention. The alcohol and depression treatment group contains the same material on alcohol, but also addresses depression in each letter.