Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
Therapy of AIDS or symptomatic HIV infection with simultaneous or alternating regimens of AZT and DDI.
Int Conf AIDS. 1992 Jul 19-24;8(1):Mo15 (abstract no. MoB 0054). Unique Identifier : AIDSLINE ICA8/92400013 Yarchoan R; Lietzau JA; Brawley O; Nguyen BY; Pluda JM; Wyvill KM; Broder S; National Cancer Institute, Bethesda, MD 20892.
Abstract:
OBJECTIVES: There are arguments to support the use of either simultaneous or alternating drug combinations in the therapy of HIV infection. The present randomized pilot study was designed to study the toxicity and activity profiles of simultaneous and alternating regimens of azidothymidine (AZT, zidovudine) and 2',3'-dideoxyinosine (ddI). METHODS: 41 patients (pts), 37 male and 4 female, with AIDS or symptomatic HIV infection and less than 350 CD4 cells/mm3 who have had less than or equal to 3 months of prior dideoxynucleoside therapy were randomized to receive either a simultaneous or an alternating regimen of AZT and ddI: (1) simultaneous AZT 300 mg/day plus ddI 250 mg/day; or (2) AZT 600 mg/day for 3 wks alternating with ddI 500 mg/day for 3 weeks. This study is still ongoing; an interim analysis is presented. RESULTS: The patients have now been followed for up to 60 weeks. Three patients, all on the alternating arm, elected to discontinue the study (for reasons unrelated to activity or toxicity). One patient on each arm has had the drugs held temporarily because of possible toxicities (anemia and hepatitis). Two pts on the simultaneous regimen, and 2 pts on the alternating regimen have developed opportunistic infections. At week 18, the mean change in CD4 cells was + 66 cells/mm3 on the simultaneous regimen and +20 cells/mm3 on the alternating regimen (P2 = 0.13, N.S. for the difference between the regimens). At week 27, the mean changes were +68 and +4 cells/mm3 respectively (P2 = 0.019). Each of 10 patients on the simultaneous regimen and 5 patients on the alternating regimen with detectable serum p24 antigen at entry have had decreases sustained for up to 30 weeks. Patients on both arms reported increased energy and appetite and had weight gain. CONCLUSIONS: Both regimens are well tolerated and provide anti-HIV activity lasting for at least 6 months. Continuation of the study should provide data to judge the relative long term merits of each regimen.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Comparative Study CD4-Positive T-Lymphocytes Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Drug Administration Schedule Drug Therapy, Combination Female Human HIV Infections/*DRUG THERAPY Leukocyte Count Male Pilot Projects Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT 921230
M92C5334
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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.
