HIV CLINICAL TRIALS
Northside Clinic participates in many clinical trials related to the treatment and management of HIV. If you are interested in participating, please ask to speak to our Clinical Trials Co-ordinator (Sian Edwards) or discuss the matter with your treating doctor.
Recruiting MID 2010
STUDY NAMES: Gilead GS-US-236-0103
WHAT IS BEING STUDIED: A new HIV medication GS-9350 versus ritonavir-boosted atazanavir when both combined with other antiretroviral medications, in patients who are previously naïve (have never taken) antiretroviral medication before. This study is international with 700 patients in total and will go over 3 years. Through this time there will be physical examinations and laboratory analyses.
SPONSOR: Gilead Sciences
RECRUITING Mid 2010
STUDY NAMES: ENCORE
WHAT IS BEING STUDIED: The effectiveness of a lower dose of efavirenz
SPONSOR: National Centre for HIV Epidemiology and Clinical Research.
ENCORE is an acronym for Evaluation of Novel Concepts in Optimization of antiRetroviral Efficacy.
Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV), could be reduced without compromising its effectiveness. Lower drug doses could have fewer side effects and would make EFV more affordable. The purpose of this study is to compare the safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV in controlling HIV as part of initial combination antiretroviral therapy. In this international, multicenter trial, 630 HIV infected patients who have not received any previous treatment for their HIV-infection will be enrolled. Participants will be randomized equally (1:1) to receive truvada (tenofovir and emtricitabine) with either the standard or reduced dose of EFV. Neither the study doctor nor the participant will know which treatment the participant is receiving. Physical examinations, laboratory analyses and questionnaires will be performed at the 11 study visits at screening, baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96. The primary aim of this study is to compare between treatment groups the proportion of patients with undetectable HIV viral load (HIV RNA < 200 copies/mL) after 96 weeks. Information on immune function, drug adherence, resistance to antiretrovirals, quality of life, mental state and HIV-related conditions will also be collected.
It is anticipated that this study will commence recruiting in April 2010. More information can be obtained from the clinic doctor or research nurse.
For more detailed information see www.clinicaltrials.gov and search for ENCOREACTIVELY RECRUITING
STUDY NAMES: Australian HIV Observational Database (AHOD)
SPONSOR: National Centre for HIV Epidemiology and Clinical Research
WHAT IS BEING STUDIED:
With patient consent anonymous data in relation to antiretroviral treatment is collected at routine clinical visits and sent twice yearly to The National Centre in HIV Epidemiology and Clinical Research to be compiled.
RECRUITING Mid 2010
STUDY NAMES: FLU 002
WHAT IS BEING STUDIED: Patients with H1N1 flu (swine flu)
SPONSOR: National Centre for HIV Epidemiology and Clinical Research
The "flu" is a common disease and usually mild but severe disease and deaths may occur. There are several types of flu viruses and they change over time. Recently, a new influenza A virus known commonly as swine flu or H1N1v has emerged. This flu has spread rapidly around the world. It is important to understand the course of illness for those who have H1N1v and the characteristics of people who do not do well. The investigators will also try to learn more about how different treatments and prior vaccination for the flu affect the course of the illness. Approximately 5,000 individuals with swine flu will be enrolled in several countries around the world.
The purpose of this observational study is to describe participants in geographically diverse locations with influenza A -- pandemic H1N1 (H1N1v) virus infection and their clinical course over a 14-day period following enrolment. Specific objectives are, among patients seeking medical care, to estimate the percentage of patients who go on to develop severe disease or complications that require hospitalization; to obtain information on risk factors for disease severity; and to establish a central repository of specimens for use in virus characterization,
Recruitment will commence in 2010 when it is established that H1N1 is circulating in the local community.
For more information see:
World Health Organisation website: www.who.int/
For detailed information see website www.clinicaltrials.gov and search for FLU 002
ACTIVE – NOT RECRUITING
STUDY NAMES: Pfizer A4001026
WHAT IS BEING STUDIED: Maraviroc – initially known as UK-427,857.
SPONSOR: Pfizer Inc.
The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy.
The A4001026 study started in 2005, is in progress, and is closed to recruitment.
For more detailed information see wwwclinicaltrials.gov and search for a4001026
ACTIVE - NOT RECRUITING
STUDY NAME: CORAL
WHAT IS BEING STUDIED: The effect of Raltegravir and/or hyper-immune bovine colostrum
SPONSOR: National Centre HIV Epidemiology and Clinical Research
The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART.
Eligible patients will be randomised to one of four arms
- Raltegravir + hyper-immune bovine colostrum placebo
- Raltegravir placebo + hyper-immune bovine colostrum
- Raltegravir + hyper-immune bovine colostrum
- Raltegravir placebo + hyper-immune bovine colostrum placebo
At Northside Clinic the Coral study started in 2009, is in progress and closed to recruitment. Unblinding will occur in 2010 after 48 weeks.
Phase 2 will continue to monitor patients for a further 48 weeks. The study at Northside Clinic will be completed mid 2011.
For more detailed information see www.clinicaltrials.gov and search for CORAL
ACTIVE – NOT RECRUITING
STUDY NAME: Mk-0518 018-20
WHAT IS BEING STUDIED: Raltagravir
SPONSOR: Merck Sharpe and Dohme
The initial study (MK-0518 018-10) was a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of MK0518 in combination with an optimized background therapy (OBT), versus optimized background therapy alone, in HIV-Infected patients with documented resistance to at least 1 drug.
The extension second phase of the study (MK-0508-018-20) study is open label -
research staff and patients are aware who has been receiving Raltegravir and who has not. Those patient who have been on Raltagravir will continue to be monitored for an extended period of 240 weeks to gather long term data.
At Northside Clinic this study is in progress, closed to recruitment, and will be completed in 2011.
For more detailed information see www.clinicaltrials.gov and search for Merck 0518
ACTIVE – NOT RECRUITING
STUDY NAMES: SPARTAC
WHAT IS BEING STUDIED: Antiretroviral therapy in primary HIV infection SPONSOR: National Centre for HIV Epidemiology and Clinical Research
SPARTAC stands for Short Pulse AntiRetroviral Therapy Atseroconversion and the study compares two different durations of treatmentfor people who have been very recently infected with HIV. These are compared to a third group of recent seroconverters who remainoff treatment altogether.
Thetrial 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. It is hoped this approach could reduce life-long exposure to antiretroviral drugs while maintaining clinical and immunological well-being.
At Northside Clinic this study started in 2004, is now closed to recruitment, and will finish in 2010.
ACTIVE – NOT RECRUITING
STUDY NAME: ALTAIR
WHAT IS BEING STUDIED: Comparing the effectiveness of three different combinations of antiretroviral regimes as initial therapy for patients with HIV infection
SPONSOR: Centre for HIV Epidemiology and Clinical Research
This study was to test the hypothisis that in treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.
The initial Altair study was completed in 2010 after extending to 96 weeks.
The preliminary finding at week 48 showed that Arm 3 (containing four NRTIs) was not as effective as the other two arms. Patients who were randomised to Arm 3 had their treatment changed at week 48 when this information was realised.
Explanation of the Altair study extension
The initial study is now complete and patients are being assessed one more time at week 144 to collect additional long term data.
For more detailed information see www.clinicaltrials.gov and search ALTAIR
ACTIVE – NOT RECRUITING
Study Name: Stalwart (extension)
What is being studied: Interleukin-2 (IL-2) in patients with HIV infection
Sponsor: National Centre HIV Epidemiology and Clinical Research
Background information
The purpose of the original stalwart study was to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects were compared with a study group that receives no IL-2 or antiretroviral therapy.
The stalwart extension study is now a follow up study for all those patients who were on the original study so they can be closely monitored as the use of short cycles of rIT-2 was seen to be ineffective.
For more detailed information see www.clinicaltrials.gov search for Stalwart
Northside Clinic will be involved in more HIV treatment studies in 2010.
Information will be posted onto this website.