Phase I study of 2'-3'-dideoxyinosine administered orally twice daily to patients with AIDS or AIDS-related complex and hematologic intolerance to zidovudine

Article Abstract:

In the study of agents to which human immunodeficiency virus (HIV) might be sensitive, a group has been identified that apparently prematurely halts normal copying of the virus's DNA. In this group are zidovudine, the first approved drug used to treat HIV infection, and 2'-3'-dideoxyinosine (ddI). Zidovudine decreases the rate of illness and death in AIDS patients, but can cause hematologic toxicity, with resulting anemia (decrease in red blood cells) or neutropenia (decrease in levels of neutrophils, a type of white blood cell). In preliminary trials, ddI was also effective, but less toxic to blood cell production. The safety and tolerance of oral ddI has been assessed further in this study of 27 patients with AIDS or AIDS related complex, all of whom were hematologically affected by zidovudine. The drug ddI was given in doses of 750 milligrams (mg) or 1,500 mg daily. Effectiveness of ddI was not compared with a placebo treatment. Levels of white blood cells and neutrophils decreased significantly over 12 weeks, as did the average volume of red blood cells. Two patients required transfusions, while one had to discontinue therapy due to neutropenia. Pain involving peripheral nerve dysfunction limited treatment in five patients. This side effect generally diminished with a decrease in dosage and was ultimately reversible. Three patients treated with 1,500 mg developed pancreatitis, one of which developed an opportunistic cryptococcus infection. Four patients had mild symptoms suggestive of pancreatitis which resolved when the drug was withheld. Three patients developed hypocalcemia (low blood calcium levels) during therapy, which reversed when ddI was discontinued and calcium supplements were given. Eleven patients gained five pounds or more, which was sustained for a minimum of four weeks. Subjective reports of increased energy were noted by individual patients. Levels of CD4 lymphocytes, immune cells preferentially attacked by HIV, increased significantly during the first part of the study, but this was not sustained. These results suggest that ddI has different side effects from zidovudine, chiefly peripheral neuropathy and pancreatitis, and appears to have antiviral effects. (Consumer Summary produced by Reliance Medical Information, Inc.)

Drug therapy, Didanosine

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Systemic treatment of AIDS-related Kaposi's sarcoma: results of a randomized trial

Article Abstract:

Kaposi's sarcoma (KS) is a rare form of cancer, characterized by skin tumors, that is often seen in patients with acquired immunodeficiency syndrome (AIDS). The cancer often spreads throughout the body if the patient does not die of other infections first and if treatment is not given. A number of chemotherapy treatments have been tested in treating KS in AIDS patients. Varying results have been obtained and a number of side effects, including further immune suppression, have developed. Low doses of the drug Adriamycin (doxorubicin) have been effective in fighting KS with minimal effects upon bone marrow function. This study compared a regimen of alternating low doses of this drug and low doses of bleomycin and vincristine (ABV) with doxorubicin alone for treating KS. Sixty-one KS patients infected with human immunodeficiency virus (HIV) were assigned to treatment with either ABV or doxorubicin alone, every two weeks. Eight of the subjects had to be withdrawn from the study because of other complications. In the 53 remaining patients, 88 percent of those receiving ABV had positive responses, while only 48 percent receiving doxorubicin alone did. Complete remission was attained in 38 percent of the patients receiving ABV but only 3 percent of those receiving doxorubicin alone. At long-term follow-up, 72 percent of the patients had died, mainly from infectious diseases. A number of treatment-related side effects, generally acceptable ones, occurred in both groups and the incidence of infectious disease was relatively low and similar in both groups during treatment. Bone marrow suppression was generally minimal, although levels of granulocytes (a type of white blood cell) did decrease in a number of patients. These results indicate that ABV therapy can be effective in treating KS without major side effects. Use of granulocyte stimulating-factors in conjunction with this treatment may help prevent the side effects that were seen. (Consumer Summary produced by Reliance Medical Information, Inc.)

AIDS (Disease), Chemotherapy, Drug therapy, Combination, Combination drug therapy, Kaposi's sarcoma

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