Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
Long term effects of zidovudine therapy in early HIV disease. Results from the Multicentre Canadian Azidothymidine Trial (MCAT).
Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no. Th.B.18). Unique Identifier : AIDSLINE ICA6/10001890 Ruedy J; Montaner JS; Schechter MT; Le T; Fanning M; Tsoukas C; Falutz J; Wells G; Child S; O'Shaughnessy M; et al; Canada
Abstract:
OBJECTIVE: To describe the long term effects of zidovudine (ZDV) therapy in early HIV infection. METHODS: Design: Multicentre, prospective, dose range finding study. Subjects: 74 HIV positive homosexual men (CDC groups IIB, III and IVC2; CD4 counts greater than 270). Intervention: Following a 3 weeks observation, volunteers were treated with ZDV 600 mg/d for 18 weeks, 900 mg/d for 9 weeks and 1200 mg/d for 9 weeks followed by a washout period of 6 weeks after which they were restarted on 1200 mg/d or the highest previously tolerated dose. Follow-up: Clinical and laboratory evaluations were performed at 3 week intervals. Pharmacokinetics: AUC, peak and trough for AZT and GAZT were measured at 48 weeks. Analysis: A case-control analysis was performed using data from the Vancouver Lymphadenopathy-AIDS Study. Cases were matched (1:1) on the basis of the previously described score using CD4, IgA and hemoglobin (Hgb). Progression to AIDS and changes in laboratory profile were compared between both groups. The same variables were correlated with pharmacokinetic parameters using ANOVA. RESULTS: Serious adverse reactions related to AZT were infrequent. Seven patients developed severe anemia (Hgb less than 100 g/L) In all cases, they recovered upon discontinuation of therapy. Case-control analysis showed a significant development of anemia, leukopenia and lymphopenia with selective decrease of CD4 in AZT treated patients. Progression to AIDS was not significantly different in both groups. Pharmacokinetic parameters failed to predict changes in laboratory profile or disease progression in AZT treated patients. CONCLUSION: Traditional surrogates of disease progression (Hgb, CD4, lymphocytes) were found to be disturbed by prolonged AZT therapy. Changes in these surrogates as well as disease progression were unrelated to serum AZT pharmacokinetics. Progression to AIDS was not significantly different in AZT treated individuals and controls, however, the statistical power was low.
Keywords: Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL Case-Control Studies Comparative Study Dose-Response Relationship, Drug Follow-Up Studies Human HIV Infections/*DRUG THERAPY Male Multicenter Studies Prospective Studies Zidovudine/ADVERSE EFFECTS/PHARMACOKINETICS/*THERAPEUTIC USE ABSTRACT MULTICENTER STUDY CLINICAL TRIAL 901230
M90C3700
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Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
