Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
A double blind study of ddl vs continued AZT among HIV+ individuals with CD4 counts 200 to 500/mm3 treated with AZT for at least six months.
Int Conf AIDS. 1992 Jul 19-24;8(1):Mo21 (abstract no. MoB 0081). Unique Identifier : AIDSLINE ICA8/92400034 Montaner JS; Rachlis A; Gill J; Beaulieu R; Tsoukas C; Fanning M; Cameron W; Lalonde R; Bergeron M; Schlech W; et al
Abstract:
OBJECTIVES: To compare efficacy and toxicity of ddl (didanosine, Videx) and AZT (zidovudine, Retrovir) in HIV infected patients with CD4 counts 200 to 500/mm3 following at least 6 months of continued AZT therapy at a dose greater than or equal to 500 mg/day. METHODS: This is a double blind study whereby patients are randomly allocated to receive AZT at a dose of 600 mg per day or ddl (powder formulation) at a dose of 334 mg/day or 500 mg/day for body weights below or above 60 kg, respectively. Clinical end points include mortality, progression to ARC and AIDS, frequency and severity of Ol's, development of neoplasms and development of HIV associated neurological disease. Additionally, the protocol has been revised to include a significant decline in CD4 count from baseline as a major outcome. Patients are monitored monthly in terms of clinical and laboratory evaluations. Ex vivo resistance to the study drugs is measured in a subset of study participants. INTERIM RESULTS: A total of 197 patients were entered as of January 31, 1992. This represents a total of 1321 patient month follow-up. There have been 29 drop-outs, 13 of these due to serious adverse drug effects (SADE). A total of 16 clinical outcome events have been diagnosed. A pre-scheduled interim analysis of the data with regard to efficacy will take place in April 1992. CONCLUSION: The present study faces a number of challenges, not unlike those posed to most long term comparative trials dealing with anti-HIV medications. Among them, the continued influx of new data (not always well scrutinized) leading to frequently changing standards of therapy; unpredictable changes in perceived importance of a particular drug or study; and wide fluctuations in the level of public and professional interest in a given drug or study. This is compounded by the number of competing clinical trials and treatment programs which can potentially act as a disincentive for enrollment in a long term, double blind comparative study. Patients are unwilling to remain in long-term trials based on clinical outcomes and this view is supported by many treating physicians. All of this emphasizes the need to develop a more expeditious process for definitive clinical testing of potentially valuable therapies. The use of surrogate markers may have a very significant beneficial effect in this context once this approach is appropriately validated.
Keywords: Canada/EPIDEMIOLOGY Comparative Study CD4-Positive T-Lymphocytes Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE Double-Blind Method Human HIV Infections/COMPLICATIONS/*DRUG THERAPY/MORTALITY Leukocyte Count Neoplasms/COMPLICATIONS/EPIDEMIOLOGY Nervous System Diseases/EPIDEMIOLOGY/ETIOLOGY Opportunistic Infections/COMPLICATIONS/EPIDEMIOLOGY Treatment Outcome Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT 921230
M92C5313
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Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
