Considerations in the selection of end points for AIDS clinical trials

Article Abstract:

The selection of end points is important when designing clinical trials for testing the effectiveness of treatments for AIDS. Although survival time is the ultimate measure of the effectiveness of the treatment, it is not a desirable or feasible end point to use in clinical trials. When selecting an end point, there are seven factors which must be taken into consideration. These include: observability of the end point in each patient, not just a subset of patients; and relevance of the end point to the outcome of the treatment. Also, the end point must be precisely defined so that ambiguity is not introduced when analyzing the effectiveness of the treatment. The amount of time necessary to reach the end point must be taken into consideration, with end points that are achieved more rapidly being desirable as long as they give appropriate results. The end point must be measured in ways that are reproducible and verifiable, so that biases that would enter into the study can be minimized; end points should not be chosen that have inherent variability among individuals or among laboratories that are doing the testing; and end points must be chosen that can be used on a widespread basis (based on the availability of equipment in various areas). The appropriateness of several end points used in clinical trials is discussed, using the example of a study of patients with early, asymptomatic HIV infection. Survival, although the ultimate end point, is not desirable because the mortality of this patient population is low and many measurable events could have occurred before death. The onset of AIDS or AIDS-related complex (ARC) can be used as end points, but there are other criteria, such as the decrease of the number of CD4 cells below 200 cell/mm cubed, that occur before AIDS or ARC develop. Use of the number of CD4 cells, although a good end point, also has its disadvantages, including variability within an individual. The level of the viral protein p24 in individuals is also a potential end point, but also has disadvantages including that not all individuals express the p24 antigen, and that there is no strong evidence that the levels of p24 relate to the duration of survival or the onset of AIDS. (Consumer Summary produced by Reliance Medical Information, Inc.)

Care and treatment, Methods, Clinical trials, HIV infection, HIV infections, Medical research, AIDS patients

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Medical Research Council AIDS directed program: program plan and research opportunities

Article Abstract:

The Medical Research Council of the United Kingdom developed a research program in 1987 for vaccine development and drug testing for human immunodeficiency virus (HIV) infections and AIDS. Over a two-year-period, the activities of the counsel have expanded to include 130 research projects. The project provides a framework for research, with a clear scientific plan. The scientific plan includes: research on many aspects of the virus, such as the cellular receptors that are involved in infectivity and immunological studies of infected individuals; the preparation of vaccines and antiviral agents; and the preclinical and clinical evaluation of the products. The program provides money for research and for training workers. Arrangements are also made for interactions with industry and collaboration of scientists from different countries and organizations, such as the World Health Organization. A list of scientists and the projects they are working on is provided. Scientists who would like to participate in the program may contact these individuals. (Consumer Summary produced by Reliance Medical Information, Inc.)

United Kingdom, Great Britain

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A methodology for building an AIDS research file using Medicaid claims and administrative data bases

Article Abstract:

Methods have been devised to use data on individuals with AIDS from the data base of the Medicaid Management Information Systems (MMIS) for purposes of health services research. The data were obtained from individuals with AIDS who received financial funds from Medicaid in the two states with the largest population of AIDS patients, New York and California, between the years 1983 and 1986. This data base can be used for additional research providing information on the epidemiology of AIDS. A program was developed to identify the majority of AIDS cases among children, women and men of all ages and in various demographic groups. Methods were also devised to define the date of the onset of AIDS, AIDS risk groups and dates of death. The population data base could be used in other research, including epidemiological aspects of the AIDS epidemic, Medicaid eligibility patterns, and the use and cost of Medicaid. An index that related severity of the disease to survival was also developed. (Consumer Summary produced by Reliance Medical Information, Inc.)

Usage, Finance, Demographic aspects, Medicaid, Databases

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