AIDS clinical trials group: phase I/II study of combination 2',3'-dideoxycytidine and zidovudine in patients with acquired immunodeficiency syndrome (AIDS) and advanced AIDS-related complex

Article Abstract:

Two medications that have been developed to treat patients with HIV (human immunodeficiency virus) infection and AIDS are zidovudine (AZT) and 2',3'-dideoxycytidine (ddC). AZT has been shown to suppress HIV infection and prolong the survival of patients with AIDS or AIDS-related complex (ARC), but also causes the side effect of myelosuppression, (inhibition of bone marrow function), which leads to blood disorders. The widespread use of AZT has also resulted in the development of AZT-resistant viral strains. The drug ddC, a more recently developed medication that is similar to AZT in its mode of action, was shown to be a powerful inhibitor of HIV, and does not cause blood disorders or drug-resistant HIV strains. However, ddC treatment has been associated with the development of severe and painful peripheral neuropathy, a disease of the peripheral nervous system. Thus, AZT and ddC do not cause the same toxicities and only AZT treatment results in the development of drug resistance. Combined treatment with low doses of both AZT and ddC may be as effective as higher doses of these antiviral agents given individually, and may reduce the incidence of adverse drug effects and development of drug resistance. The effectiveness and safety of six different dose regimens of AZT and ddC are being assessed in patients with AIDS or ARC in a phase I/II clinical trial, or initial human study. The final results are not yet available, but the study design and hypotheses are discussed. Physicians and patients are cautioned not to devise their own combinations of these drugs, because the clinical trials are necessary for evaluating the safety and effectiveness of AZT and ddC. (Consumer Summary produced by Reliance Medical Information, Inc.)

Health aspects, Dosage and administration, Zidovudine

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Safety and tolerance of dideoxycytidine as a single agent: results of early-phase studies in patients with acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex

Article Abstract:

HIV, the human immunodeficiency virus, can be effectively treated with drugs that inhibit the viral enzyme known as reverse transcriptase, which is essential for the replication, or production, of the HIV virus. One such drug is zidovudine, or AZT. Phase I and II clinical trials, which are the initial human studies of a new drug, are currently underway to test the effectiveness and safety of a recently developed reverse transcriptase inhibitor, dideoxycytidine (ddC), for treating HIV-1 infection. This new antiviral agent is effective against HIV-1 infection, as indicated by decreased levels of the p24 antigen, which is an HIV marker, and by increased levels of CD4+ lymphocytes, which are immune cells that are particularly vulnerable to destruction by HIV. However, ddC treatment has been associated with the occurrence of severe peripheral neuropathy, or nerve disease, which is more likely with increasing doses of ddC. Using lower doses of ddC reduces the incidence of adverse drug effects, and the treatment remains effective at decreasing p24 antigen levels and increasing CD4+ lymphocyte numbers. These early clinical studies have been useful in determining the range of safe and effective doses of ddC for treating HIV infection. In addition, the results suggest that the safety and activity can be retained with long-term, low-dose use of ddC. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Clinical trials

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