Open AccessA Multicenter, Randomized, Controlled Trial of Three Preparations of Low-Dose Oral α-Interferon in HIV-Infected Patients With CD4+ Counts Between 50 and 350 cells/mm3
Author(s) -
Beverly Alston,
Ellenberg Jh,
Standiford Hc,
K Muth,
Ana Martı́nez,
Wayne Greaves,
Jones O. Kumi
Publication year - 1999
Publication title -
journal of acquired immune deficiency syndromes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.162
H-Index - 157
eISSN - 1944-7884
pISSN - 1525-4135
DOI - 10.1097/00126334-199912010-00005
Subject(s) - medicine , placebo , clinical endpoint , randomized controlled trial , adverse effect , weight loss , clinical trial , human immunodeficiency virus (hiv) , gastroenterology , immunology , obesity , alternative medicine , pathology
To evaluate the effectiveness of low-dose oral alpha-interferon (alpha-IFN), 247 HIV-infected study subjects received placebo, Alferon LDO, Veldona, or Ferimmune in a randomized, double-blind trial. Subjects had CD4+ counts between 50 and 350 cells/mm3 and HIV-related symptoms at entry. Study subjects rated the severity of eight symptoms using a symptom burden index (SBI). Study endpoints included changes in SBI, weight, CD4+ count, and Karnofsky score between baseline and the 24-week visit. The SBI outcome and weight were measured in 99 and 106 study subjects, respectively, at both the baseline and 24-week visits. Baseline SBI scores ranged from 5.4 to 7.9 in the four arms. No clinically important or statistically significant differences were found among the four arms with regard to SBI or weight change over the 24-week period. There were also no significant differences among the arms for CD4+ cell count and Karnofsky score. Few adverse reactions were noted in any arm, and there were no significant differences between arms. Although the trial was designed to enroll 560 study subjects and was prematurely terminated because of slow accrual and discontinuations of participants, the small differences among the arms in the primary and secondary endpoints do not support claims of efficacy for the measures studied.