A 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
| Autor: | Ana Martinez, Katherine Muth, Jones O. Kumi, Jonas H. Ellenberg, Harold C. Standiford, Beverly Alston, Wayne Greaves |
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| Rok vydání: | 1999 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Alpha interferon Treatment research Placebo Gastroenterology law.invention Acquired immunodeficiency syndrome (AIDS) Randomized controlled trial Oral administration law Immunopathology Internal medicine Clinical endpoint medicine Hiv infected patients Pharmacology (medical) Interferon alfa biology business.industry Weight change Immunotherapy medicine.disease biology.organism_classification Clinical trial Infectious Diseases Lentivirus Immunology business medicine.drug |
| Zdroj: | Journal of Acquired Immune Deficiency Syndromes. 22:348 |
| ISSN: | 1525-4135 |
| DOI: | 10.1097/00042560-199912010-00005 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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