Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
ACTG protocol 116B/117; clinical outcome of a randomized double blind controlled study of DDI and ZDV. AIDS Clinical Trials Group. 116B/117 Study Team.
Abstract:
OBJECTIVES: We conducted a large multi-centered, randomized, controlled study to compare the clinical efficacy and safety of ZDV with didanosine (ddI) in subjects with at least 16 weeks of prior ZDV treatment and tolerant of ZDV. The primary study endpoints were the incidence of death and new opportunistic infections. METHODS: ACTG 116B/117 was a double-blind randomized trial comparing the clinical efficacy and toxicity of 600 mg daily of ZDV with two dose levels, both weight adjusted, 500 mg and 750 mg daily of didanosine in ZDV tolerant subjects with a minimum 16 weeks of prior ZDV therapy. The study was conducted at 37 participating institutions of the ACTG and four additional independent centers. Subjects were older than 12 years with KPS of at least 60% and relatively normal laboratory measures. Eligibility criteria included CD4 T lymphocytes less than 300 cells/microL for AIDS/ARC subjects and less than 200 for asymptomatic subjects. 913 subjects accrued to this study between November 1989 and March 31, 1991. Toxicity monitoring included adverse clinical effects, adverse laboratory effects, dose reduction or discontinuation of study medications. The comparisons between treatment groups of primary clinical endpoints and secondary clinical endpoints will be based on the use of time-to-failure methods, in an intent-to-treat analysis. The study ended in 11/1991; median followup was 11.5 months. RESULTS: Initial baseline characteristics of the study group are outlined below. TABULAR DATA, SEE ABSTRACT VOLUME. Preliminary information suggests that CD4 T lymphocytes increased in subjects treated with ddI compared with ZDV. CONCLUSIONS: The randomization scheme provided an equal number of subjects with similar baseline characteristics. Clinical endpoints, the relative toxicities between treatment arms, and trends in surrogate laboratory markers will be presented based on the final data set. The relative risk of opportunistic infections or death based on the total duration of ZDV therapy will also be evaluated. These results will clarify the role of ddI therapy for the treatment of HIV infected individuals treated with ZDV for a minimum of 16 weeks. Implications from this trial for the design of future clinical trials will be discussed.
Keywords: Adolescence Adult CD4-Positive T-Lymphocytes Didanosine/*THERAPEUTIC USE Double-Blind Method Drug Tolerance Ethnic Groups Female Human HIV Infections/COMPLICATIONS/*DRUG THERAPY/MORTALITY Incidence Leukocyte Count Male Opportunistic Infections/COMPLICATIONS/EPIDEMIOLOGY Treatment Outcome Zidovudine/*THERAPEUTIC USE ABSTRACT 921230
M92C5312
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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.
