A phase I study of recombinant human interferon-alpha 2a or human lymphoblastoid interferon-alpha n1 and concomitant zidovudine in patients with AIDS-related Kaposi's sarcoma

Article Abstract:

A phase I trial was conducted with 56 patients who were infected with the human immunodeficiency virus type 1 (HIV-1) and had Kaposi's sarcoma (KS). The safety, maximum dose that could be tolerated, and effectiveness of treatment with interferon-alpha given at the same time as zidovudine were evaluated. Interferon-alpha is a cytokine (a cellular factor) which has been shown to cause increased immune reactions against the Kaposi's sarcoma tumor and to inhibit the replication of the virus. Zidovudine has also been shown to inhibit HIV-1 and improve the disease status of those infected with HIV, including prolonging life. Both drugs together are thought to increase the rate of inhibition of the virus. The drugs were given together in various dose combinations for eight weeks, with a 48-week follow-up. At higher doses of the combination of the two treatments, an increase in the number of CD4+ helper T cells was seen, as well as suppression of the presence of viral proteins, indicating the inhibition of the infection. Anemia (destruction of red blood cells), neutropenia (destruction of white blood cells), and hepatotoxicity (destruction of liver cells) occurred at toxic levels of the drugs. The highest dose at which neutropenia was not seen was 1,200 milligrams (mg) of zidovudine and 9 mu of interferon-alpha per day. The highest dose at which hepatotoxicity was not seen was 600 mg of zidovudine and 27 mu of interferon-alpha per day. With the three types of toxicities taken into consideration, 600 mg of zidovudine and 18 mu of interferon-alpha per day were determined to be the maximum tolerated doses for the combination of the two drugs. Tumor regression was seen in 47 percent of the patients, and was associated with greater survival rates. This study shows that an intermediate dose of interferon-alpha and low doses of zidovudine do not appear to be toxic to patients with HIV-1 infection and Kaposi's sarcoma and can lead to improvement in disease status, including tumor regression and increased survival. (Consumer Summary produced by Reliance Medical Information, Inc.)

Dosage and administration, Interferon

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Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection: a randomized, double-blind, placebo-controlled trial

Article Abstract:

Combining nevirapine, zidovudine, and didanosine appears to maintain CD4 counts and reduce viral load more effectively than zidovudine and didanosine alone. However, patients taking the triple combination were more likely to develop severe rash. Researchers randomly assigned 398 HIV-infected patients with prior prolonged nucleoside therapy and CD4 cell counts of 350 or less to 48 weeks of treatment with either all three drugs or to zidovudine and didanosine plus placebo. CD4 counts declined an average of 15% with the triple combination versus 33% with the double combination. Viral titers in white blood cells declined by 54% and HIV-1 RNA plasma content declined by 20% with the triple combination versus a viral titer decline of 5% and an RNA plasma content rise of 44% with the double combination. However, similar percentages of both groups, 17% and 14% respectively, experienced disease progression or death, and 9% of those taking the triple combination experienced severe rash versus 2% taking the double combination.

Evaluation, Antiviral agents, Drug therapy, Combination, Combination drug therapy, Didanosine

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Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma

Article Abstract:

Doxorubicin may not be an effective treatment for AIDS patients who have Kaposi's sarcoma. Kaposi's sarcoma is a cancer that affects the skin and occasionally the lymph nodes and viscera, or internal organs. Among 53 AIDS patients suffering from Kaposi's sarcoma who were treated with 15 milligrams of doxorubicin per square meter once a week, 26 had cutaneous (skin) disease with no symptoms and 27 had visceral disease with fluid accumulation and a history of opportunistic infections. Of 50 patients for whom treatment response was evaluated, 10% experienced a partial response to treatment, 64% experienced a minor response, 24% experienced no response and 2% experienced disease progression. Twenty percent of the patients with cutaneous disease experienced a partial response to treatment, compared to none of the patients with visceral disease.

Health aspects, Doxorubicin

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