Book contents
- Frontmatter
- Contents
- Introduction
- Participants
- Non-Participant Contributors
- Part 1 Transmissible diseases with long development times and vaccination strategies
- Part 2 Dynamics of immunity (development of disease within individuals)
- Part 3 Population heterogeneity (mixing)
- Part 4 Consequences of treatment interventions
- Conflicts between the individual and communities in treatment and control
- The design and analysis of HIV clinical trials
- A theory of population dynamics used for improving control of viral diseases: AZT chemotherapy and measles vaccination policy
- The ONCHOSIM model and it use in decision support for river blindness control
- Invited Discussion
- Invited Discussion
- Hydatid disease
- Vaccines and herd immunity: consequences for vaccine evaluation
- An epidemiological approach to the evaluation of disease control strategies for intestinal helminth infections: an age structured model
- The control of directly transmitted infections by pulse vaccination: concepts and preliminary studies
- Operational models for the prevention of blindness
- Part 5 Prediction
The design and analysis of HIV clinical trials
Published online by Cambridge University Press: 04 August 2010
- Frontmatter
- Contents
- Introduction
- Participants
- Non-Participant Contributors
- Part 1 Transmissible diseases with long development times and vaccination strategies
- Part 2 Dynamics of immunity (development of disease within individuals)
- Part 3 Population heterogeneity (mixing)
- Part 4 Consequences of treatment interventions
- Conflicts between the individual and communities in treatment and control
- The design and analysis of HIV clinical trials
- A theory of population dynamics used for improving control of viral diseases: AZT chemotherapy and measles vaccination policy
- The ONCHOSIM model and it use in decision support for river blindness control
- Invited Discussion
- Invited Discussion
- Hydatid disease
- Vaccines and herd immunity: consequences for vaccine evaluation
- An epidemiological approach to the evaluation of disease control strategies for intestinal helminth infections: an age structured model
- The control of directly transmitted infections by pulse vaccination: concepts and preliminary studies
- Operational models for the prevention of blindness
- Part 5 Prediction
Summary
Introduction
Clinical trials have been conducted in patients with AIDS or HIV for ten years. There is no obvious reason why the principles underlying good clinical trial design should be any different for trials on HIV than for any other disease. However, the social setting of the infection has demanded that some of these principles should be more clearly justified. Attempts have been made by some trialists to conduct trials that avoid the need for randomisation or placebos, or attempt to use early signs of disease progression or laboratory markers rather than death as an end-point. This paper will illustrate these issues by comparing the design and analysis of two large European studies, coordinated by the MRC at the Brompton Hospital (in collaboration with INSERM in Paris), with other trials studying the same questions.
Summary of some of the key trials
Trials on the early use of Zidovudine
Zidovudine is an anti-HIV drug which was shown in one study to reduce mortality in patients with advanced HIV disease over a median study time of four months. On the basis of this study, the drug has been licensed and widely used.
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- Models for Infectious Human DiseasesTheir Structure and Relation to Data, pp. 344 - 347Publisher: Cambridge University PressPrint publication year: 1996