A pilot study of the bioavailability and pharmacokinetics of 2',3'-dideoxycytidine in patients with AIDS and AIDS-related complex

Article Abstract:

Studies have shown that certain types of chemical compounds, the 2' and 3' substituted nucleoside analogs, can prevent the replication of multiplication of the human immunodeficiency virus (HIV). Zidovudine, one of the first 2' and 3' substituted nucleoside analogs, is currently used to treat acquired immunodeficiency syndrome (AIDS) and AIDS-related complex (ARC), which are caused by HIV infection. Another nucleoside analog, 2',3'-dideoxycytidine (ddC), has been shown to be very potent in preventing HIV replication. The pharmacokinetics of ddC, or the characteristics of its metabolism and action, have not been studied extensively in humans. Hence, these features and the bioavailability of ddC, or amount of drug available for therapeutic effect after ingestion or injection, were assessed in eight patients with AIDS or ARC. The maximum levels of ddC achieved in the blood, the time needed to reach these maximum levels, the rate of removal from the body (clearance), and the extent to which the drug penetrates certain body tissues, are reported. The half-life of ddC, or time needed for blood levels of ddC to decrease by 50 percent, ranged from 0.95 to 2.0 hours and was not related to dose or methods of administration. The bioavailability of ddC oral tablets ranged widely from 54 to 127 percent, and single doses of this nucleoside analog were well tolerated by patients. The results show that ddC given by mouth is rapidly and thoroughly absorbed, and also rapidly eliminated. (Consumer Summary produced by Reliance Medical Information, Inc.)

Drug metabolism, Zalcitabine

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Incorporation of trial results into clinical practice

Article Abstract:

Clinical trials testing the effectiveness of drugs in AIDS patients must be expanded to include many types of patients, including minorities, intravenous drug users, and those of different socioeconomic classes. But there are problems with expanding the populations of individuals who participate in clinical trials. One trial is discussed that measured the reduction of the doses of multiple drugs that were being given at the same time. The trial included patients who had a wide range of opportunistic infections. It was questioned how the results could be analyzed because such diversity existed among the participants. Issues involved in the development of drugs for treating AIDS and HIV infections are discussed. These include the use of surrogate markers, such as laboratory markers, to analyze the effectiveness of drugs, rather than using clinical status such as the progression of disease. The use of surrogate markers will expedite the results of clinical trials. The data that are being accumulated from the clinical trials must be analyzed and released to the community as rapidly and appropriately as possible. There is a need for improved communication and interactions among the government, academic researchers, pharmaceutical companies, and patient advocacy groups. The costs and benefits of various types of clinical trials must be evaluated, so that the best type of trials can be conducted. (Consumer Summary produced by Reliance Medical Information, Inc.)

Medicine, Pharmaceutical industry, Practice, Physicians, Medical professions, Clinical trials, Information services

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Anthropometric, metabolic, and immunological effects of recombinant human growth hormone in AIDS and AIDS-related complex

Article Abstract:

A pharmacological dose of recombinant (genetically engineered) human growth hormone (rhGH) may prevent wasting in patients with AIDS or AIDS-related complex (ARC). Wasting is weight loss caused by different metabolic changes associated with AIDS or ARC. Among ten patients with AIDS or ARC who had lost at least 10% of their body weight during the 12 weeks preceding treatment, four were treated with five milligrams (mg) of rhGH (a pharmacological dose) and five were treated with 2.5 mg (a physiological dose) every other day. Patients treated with a pharmacological dose of rhGH gained an average of three kilograms (kg) after 12 weeks of treatment, compared with an average of 0.7 kg among the patients treated with a physiological dose. Patients in the pharmacological dose group experienced a significant increase in muscle power and endurance, but those in the physiological dose group only experienced a slight improvement in muscle power.

Health aspects, Somatotropin, AIDS-related complex

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