New study confirms the existence of 'trial effect' in HIV clinical trials
A new study by investigators from the University of North Carolina at Chapel Hill School of Medicine has confirmed the existence of a "trial effect" in clinical trials for treatment of HIV.
Trial effect is an umbrella term for the benefit experienced by study participants simply by virtue of their participating in the trial. It includes the benefit of newer and more effective treatments, the way those treatments are delivered, increased care and follow-up, and the patient's own behavior change as a result of being under observation.
"Trial effect is notoriously difficult to test," said Prema Menezes, PhD, assistant professor of medicine at UNC and lead author of the study. "Our study used the objective finding of viral load to test our hypothesis," she said.
Researchers compared viral suppression among patients who began highly active antiretroviral therapy (HAART) in a clinical trial with patients who received HAART in routine clinical care in two different time periods, 1996-1999 and 2000-2006. They found clear evidence of a trial effect during the earlier period, but not during the later period. Researchers offer that improvements to antiretroviral therapy (fewer pills and fewer side effects), and the change in attitude to HIV, which has come to be seen by many as a chronic, but treatable infection, may be among the explanations for the lack of demonstrable trial effect in the later period.
"This is the first study to clearly demonstrate a trial effect in HIV clinical trials, and this has important implications moving forward," Menezes said. Documentation of a clinical trial effect should be considered when interpreting the generalizability of clinical trial results. At the same time, the fact that no trial effect was observed in the current HAART period argues that the efficacy demonstrated in clinical trials is likely to predict the effectiveness of the therapy in broader treatment populations. Clinicians and public health officials may have increased confidence that treatment guidelines based on clinical trial data are relevant to routine clinical care.
More information: Menezes P, Miller WC, Wohl DA, Adimora AA, Leone PA, et al. (2011) Does HAART Efficacy Translate to Effectiveness? Evidence for a Trial Effect. PLoS ONE 6(7): e21824. doi:10.1371/journal.pone.0021824
Provided by Public Library of Science
- Gene therapy shows promise as weapon against HIV Feb 17, 2009 | not rated yet | 0
- International HIV/AIDS study is halted Jan 19, 2006 | not rated yet | 0
- Adaptive trial designs could accelerate HIV vaccine development Apr 20, 2011 | not rated yet | 0
- Researchers present Phase II HIV gene therapy trial data at CROI 2010 Feb 19, 2010 | not rated yet | 0
- Study finds early HAART during TB treatment boosts survival rate in co-infected people Jul 22, 2010 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Classical and Quantum Mechanics via Lie algebras
Apr 15, 2011 I'd like to open a discussion thread for version 2 of the draft of my book ''Classical and Quantum Mechanics via Lie algebras'', available online at http://lanl.arxiv.org/abs/0810.1019 , and for the...
- More from Physics Forums - Independent Research
More news stories
(Medical Xpress)—A new study by researchers in the US has shown that an ancient virus can be modified to help in the fight against the simian immunodeficiency virus SIV, which is the equivalent in monkeys ...
HIV & AIDS 58 minutes ago | not rated yet | 0 |
Detection of HIV antibodies is used to diagnose HIV infection and monitor trials of experimental HIV/AIDS vaccines. New, more sensitive detection systems being developed use microspheres to capture HIV antibodies ...
HIV & AIDS 16 hours ago | 5 / 5 (1) | 0
(HealthDay)—For HIV-infected individuals with recurrent Clostridium difficile infection, fecal microbiota therapy is feasible, according to a letter published in the May 21 issue of the Annals of Intern ...
HIV & AIDS May 22, 2013 | not rated yet | 0
Canadian health authorities lifted Wednesday what was effectively a ban on gay men giving blood, announcing new rules making men who have not had sex with men in the past five years eligible.
HIV & AIDS May 22, 2013 | not rated yet | 1
How can healthy people who hear voices help schizophrenics? Finding the answer for this is at the centre of research conducted at the University of Bergen.
50 minutes ago | 3 / 5 (1) | 0
Researchers from London's Kingston University have begun a two-year study which could help prolong the lives of people with colorectal tumours.
40 minutes ago | not rated yet | 0
New research presented today shows that formation of new neurons in the hippocampus - a brain region known for its importance in learning and remembering - could cause forgetting of old memories by causing a reorganization ...
30 minutes ago | not rated yet | 0
Ernie Pyle – an iconic war correspondent in World War II – reportedly said "There are no atheists in foxholes." A new joint study between two brothers at Cornell and Virginia Wesleyan found that only ...
33 minutes ago | not rated yet | 0
(Medical Xpress)—Research by Stanford scholar Emma Seppala at the Center for Compassion and Altruism Research and Education found that post-traumatic stress disorder decreased in veterans who participated ...
1 hour ago | not rated yet | 0
The individualisation of drug treatments to support patients to self-manage their conditions is a concept that sits at the heart of policy, but a recent study in BMJ Open shows that there is no concrete defini ...
50 minutes ago | not rated yet | 0