Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
Randomized prospective trial of two regimens of zidovudine (ZDV) in AIDS and ARC patients: 1200 mg/day vs 600 mg/day.
Int Conf AIDS. 1990 Jun 20-23;6(1):139 (abstract no. Th.B.21). Unique Identifier : AIDSLINE ICA6/10002190 Salmon D; Detruchis P; Matheron S; Bouvet E; Levacher M; Leport C; Hopital Claude Bernard - Bichat, Paris, France
Abstract:
OBJECTIVES: To compare tolerance and efficacy of two regimens of ZDV: full dose (FD) 200 mg every 4 hours and half dose (HD) 200 mg every 8 hours in AIDS and ARC patients (pts). METHODS: From 4/88 to 6/89, 76 pts were randomly assigned to receive either FD, or HD of ZDV. Inclusion criteria were Karnovsky index greater than or equal to 70%, Hb greater than or equal to 12 g/d/, neutrophils (PMN) greater than or equal to 1000/mm3, CD4 cell count greater than or equal to 100/mm3. Tolerance and efficacy were assessed monthly and submitted to an intend to treat analysis. Doses were adjusted to hematological values. RESULTS: At day O, the 2 groups were comparable for HIV infection stage (25 ARC, 11 AIDS pts in FD; 25 ARC, 15 AIDS pts in HD), risk factors, sex, Hb, PMN and CD4 cell counts. Mean duration of follow-up was 12 months (3-20). Four patients were lost to follow-up. Mean delay before first interruption or dose reduction was 96+/-115 days in FD and 177+/-148 days in HD (p less than 0.05). At the end of follow-up, 47% FD pts vs 72% Hd pts had received greater than or equal to 75% of the intended dosage (p less than 0.05). Mean values of Hb, and PMN did not differ at day 0, M6, M12 and between FD and HD. Platelets increased in FD and were higher in FD than in HD from M3 to M5 (p less than 0.05). Adverse effects were anemia (FD:13, HD:9), thrombopenia (FD:3, HD:2), neutropenia (FD:9, HD:15), myalgias (FD:1, HD:5). Karnovsky index remained stable and a similar gain of weight (+2.5 kg) was seen at M6 in both groups. A transient increase in CD4 cell count at M3, did not differ between FD and HD. Kaposi sarcoma, opportunistic infections (OI) and death occurred respectively in 1, 13(21 OIs), 3 pts FD, and 5, 10(22 OIs), 6 pts HD. AIDS developed in 11/25 ARC-FD and in 3/25 ARC-HD (p less than 0.01). This difference was not observed if the 6 first weeks were excluded (4/20 FD vs 2/24 HD). CONCLUSION: Thus (1) adverse events were not different between FD and HD pts, (2) however FD pts received a lower percentage of their intended dosage, and reduced or stopped ZDV earlier than HD pts, (3) HD regimen does not seem less effective than FD regimen.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY AIDS-Related Complex/*DRUG THERAPY Comparative Study Dose-Response Relationship, Drug Drug Therapy, Combination Female Follow-Up Studies Human Male Prospective Studies Randomized Controlled Trials Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL 901230
M90C3697
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
