Prolonged HIV medications interruptions are possible! - A break for HIV-infected persons MONTREAL, Sept. 7 /CNW Telbec/ - Prolonged HIV medications interruptions are possible in adults infected with HIV for long periods of time by using a complex therapeutic strategy that includes vaccination with Remune (TM) (a therapeutic vaccine). The results of this research trial have been presented today by Dr. Emil Toma, a microbiologist and infectious diseases specialist at Centre Hospitalier de l'Université de Montréal (CHUM) and a clinical professor at University of Montreal, before 1,000 researchers gathered at the AIDS Vaccine 2005 International Conference, organised by the Canadian Network for Vaccines and Immunotherapeutics (CANVAC). Medications interruptions diminish drug toxicities and metabolic complications, improve quality of life and reduce the cost of treatment. This innovative Montreal-based study, designed by Dr. Emil Toma and colleagues, was conducted at Hôtel-Dieu Hospital from CHUM in collaboration with the researchers from CHUM, Ste-Justine Hospital Research Centre, McGill University and Canadian HIV Trials Network (CTN).
The study in brief
This study, extended over five and a half years, actually tested the hypothesis whether therapeutic vaccination with Remune(TM), initiated after intensification of the anti-HIV therapy and the use of GM-CSF (a bone marrow stimulant), will allow for antiretrovirals' interruptions for the extended periods of time in the presence of vaccine boosters. This therapeutic strategy aimed, firstly, at targeting HIV reservoirs (cells or organs where the HIV medications are less active) and secondly, at augmenting the HIV-specific immunity in order to allow the individual to fight off HIV without medications, at least for certain periods of time.
The study in detail
This study, designed in 1998-1999, was initiated in March 2000 and was continued until August 2005 involving 10 adults with chronic HIV infection, 5 of whom already suffered from an AIDS complication. It is one of the first and the longest study that evaluated the impact of a complex therapeutic strategy and a therapeutic vaccine on HIV medications interruptions in adults with chronic HIV infection. The study participants had a 6-month intensification of their anti-HIV treatment. On the 5th month of intensified therapy, the first dose of Remune(TM) vaccine was given. One month later, HIV medications were stopped but the vaccine was administered every 3 months for 3 years. The HIV treatment was resumed and again stopped according to the CD4+ T cell counts (a measure of immunity or defence against the virus) and to HIV viral load (the amount of HIV in the blood). For the last two years, the study participants have been receiving intermittent individualized treatments without therapeutic vaccine. The participants have been able to stay off HIV medications (antiretrovirals) for a median 53 % of time since the first interruption (between 35 % and 85 %). The viral load increased as the antiretrovirals were stopped but significant decreases were noted at the subsequent interruptions. The patients developed an important HIV-specific immunity and a balanced natural immunity was assessed by their cytokines blood profiles. These study participants have been their own controls. Changes in the presence or absence of a therapeutic intervention have been measured, a robust experimental approach to quantitate effects of treatment in small groups of patients. The duration of treatment interruption correlated directly with CD4+ T cell counts these patients had before going on triple anti-HIV therapy. In fact, this study establishes that the novel treatment strategies (even though complex) in conjunction with a therapeutic vaccine, might enable HIV- infected persons to benefit from the supervised HIV medications interruptions.
The collaborators
This study involved the collaboration from several companies, i.e., Cangene Corporation (Winnipeg, Manitoba), Agouron Pharmaceuticals (San Diego, California), Immune Response Corporation (Carlsbad, California), Hoffman-La- Roche Limited (Mississauga, Ontario). The study was partially funded by CTN (Canadian HIV Trials Network), le Fonds de recherche en santé du Québec (FRSQ), and CANFAR. The hypothesis and the design of this study were presented at the Second Annual Meeting of RIGHT (Research Institute for Genetic and Human Therapy), in Washington, D.C., in April 1999.
The Centre hospitalier de l'Université de Montréal (CHUM) is a university hospital centre that provides specialized and ultraspecialized services to a regional and supraregional clientele. CHUM also offers general and specialized hospital services for its immediate service area. These services, which contribute to teaching and research and to the evaluation of health-care technologies and intervention methods, are provided on an integrated network basis. CHUM also contributes to the ongoing promotion of health through its front-line services. CHUM was formed with the merger of three Montreal hospitals: Hôtel-Dieu, Notre-Dame and Saint-Luc. CHUM's 10,000 employees, 900 doctors, 330 researchers, 5,000 students and trainees and 800 volunteers serve more than half a million patients every year. www.chumontreal.qc.ca |