2,3-dideoxyinosine (ddI) in patients with the acquired immunodeficiency syndrome or AIDS-related complex

Article Abstract:

Dideoxyinosine (ddI) is a drug currently under evaluation for use in treating AIDS (acquired immunodeficiency syndrome) and AIDS-related complex. The only drug presently approved for treating these conditions, zidovudine (AZT), has considerable toxicity and appears to become less effective after one year of therapy. Results of a controlled study of ddI's effects on 37 patients with AIDS (17 patients) or AIDS-related complex (20 patients) are presented. In this dose-escalation study, increasing doses were administered as long as toxicity did not develop. The drug was administered intravenously for the first two weeks, then orally during subsequent weeks. Patients were evaluated for general health, blood levels of enzymes and other factors, and the number of white blood cells (lymphocytes); lymphocytes typically decrease in AIDS patients. Thirty subjects had previously received zidovudine, and most could no longer tolerate this drug. After ddI treatment, eight patients developed a painful neuropathic syndrome (nerve inflammation) and five others developed pancreatitis (inflammation of the pancreas). Symptoms of these disorders disappeared in most patients when ddI was discontinued. Significant decreases occurred in p24 antigen levels, which are associated with human immunodeficiency virus (HIV), the virus believed to cause AIDS. An increase occurred in the number of CD4-positive T cells, which is an important indicator of antiviral efficacy. The maximum tolerated dose of ddI was determined to be 12 mg per kilogram of body weight per day. Either a small weight gain or an improved clinical response was observed in 74 percent of the patients. Overall, it appears that ddI shows promise as a therapeutic agent against AIDS or AIDS-related complex, and larger-scale, rigorous, clinical trials have now begun. (Consumer Summary produced by Reliance Medical Information, Inc.)

AIDS-related complex

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Once-daily administration of 2,3-dideoxyinosine (ddI) in patients with the acquired immunodeficiency syndrome or AIDS-related complex

Article Abstract:

Dideoxyinosine (ddI) is a drug that is considered a potential treatment for AIDS (acquired immunodeficiency syndrome) and AIDS-related complex. Zidovudine (AZT) is the only drug currently approved for treating these conditions, and has considerable toxicity. It also appears to become less effective after one year of therapy, so new agents are needed. Since ddI seems to remain in cells as long as 12 hours, it may be effective in stopping the replication of HIV (human immunodeficiency virus, the virus associated with AIDS), even if administered infrequently. This possibility was tested in 17 AIDS patients and 17 patients with AIDS-related complex. The patients received ddI intravenously once each day for two weeks, and then took one tablet orally each day for several weeks. Patients' overall clinical condition, immune function, and blood levels of p24 antigen (a viral protein that indicates how efficiently HIV is replicating) were monitored. Pancreatitis (inflammation of the pancreas) developed in two patients, painful peripheral neuropathy (nerve inflammation) in one, and changes in enzyme levels reflecting liver function occurred in five individuals. Increases in white blood cell population and in CD4 and CD8 lymphocytes (a type of white blood cell) also were noted. Levels of p24 antigen decreased in 12 of the 19 patients who were positive for p24 antigen when the study began. Energy and appetite increased and fatigue lessened for 85 percent of the 27 patients who completed at least six weeks of treatment with ddI. The maximum tolerated oral dose of ddI was 20.4 mg per kilogram of body weight per day. Overall, ddI shows promise for treating patients with severe HIV infection, but randomized, controlled studies are essential to accurately assess its efficacy. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter

Article Abstract:

Combination drug therapy with zidovudine plus didanosine or zalcitabine does not appear to prolong life in AIDS patients. This was demonstrated in a study of 1,102 AIDS patients who took zidovudine alone, zidovudine and didanosine or zidovudine and zalcitabine. After an average follow-up of three years, death rates were similar in the three groups. Those taking combination therapy also experienced more side effects. It is possible that combination therapy could benefit AIDS patients who have not taken zidovudine for long periods of time.

Zidovudine, Drug therapy, Combination, Combination drug therapy, Zalcitabine

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