The National Institute of Allergy and Infectious Diseases (NIAID) held a symposium, entitled "Methodological Issues in AIDS Clinical Trials", on November 20-21, 1989. Topics pertaining to comparative drug trials, especially those designed to test if a drug should be approved for patient use, were discussed. Since AIDS is an epidemic, it is questionable whether conventional approaches to clinical research should be used or whether there are ways that are more efficient and more responsive to the needs of the patients. Although AIDS is an epidemic, there is the potential for the discovery of a cure or methods of prevention through research. The discovery that azidothymidine (AZT) prolongs the life of AIDS patients has stimulated interest in developing other drugs that are effective against the virus. At present, there are at least 10 new drugs being tested in clinical trials that appear to be promising agents against the human immunodeficiency virus (HIV). The pharmaceutical industry is committed to finding new drugs, and the Food and Drug Administration has increased the number of staff members assessing these drugs; this will allow more rapid evaluation. The NIAID has established a coordinated national clinical research effort, known as the AIDS Clinical Trials Group (ACTG), and a community clinical research program. Clinical researchers and physicians are needed to become involved. Biostatisticians must also be involved in the design, monitoring, and evaluation of AIDS clinical trials. The AIDS patients are also included; they are well-educated about their disease and contribute to the planning of the clinical trials. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of Acquired Immune Deficiency Syndromes
Safety, pharmacokinetics, and antiviral response of CD4-immunoglobulin G by intravenous bolus in AIDS and AIDS-related complex
Recombinant CD4 immunoglobulin G (rCD4-IgG) may become an effective treatment for AIDS patients if the optimal dosage and concentration can be worked out. Researchers studied the effect of rCD4-IgG given by intravenous injection to 22 AIDS patients. Only one patient experienced serious side effects from the treatment. Although blood levels of rCD4-IgG increased with each dose, the levels did not reach a concentration that could effectively inactivate the AIDS virus. The concentration of CD4-IgG in this study, however, was higher than in previous studies. After this study was completed, another form of a CD4 treatment was designed that reached concentrations that could inactivate HIV.
Publication Name: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology