Linked Life Data

1670585

Source:http://linkedlifedata.com/resource/pubmed/id/1670585

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
1991-1-22
pubmed:abstractText
To determine the safety, maximum tolerated dose, and preliminary efficacy of concomitant interferon-alpha and zidovudine therapy in AIDS-related Kaposi's sarcoma (KS), 56 patients with biopsy-proven KS and documented human immunodeficiency virus type 1 (HIV) infection were enrolled into a phase I study. Interferon-alpha was given intramuscularly at a dose of 9, 18, or 27 mu once a day and zidovudine was administered as 100 or 200 mg every 4 h for 8 weeks followed by a 48-week maintenance period. The major toxicities were anemia, neutropenia, and hepatotoxicity. Neutropenia was dose limiting with 1,200 mg of zidovudine/day and the lowest dose of interferon-alpha (9 mu/day). Hepatotoxicity was dose limiting with 27 mu of interferon and 600 mg of zidovudine/day. Cumulative dose-related anemia or neutropenia was not seen during long-term follow-up. The maximum tolerated doses for the combination were defined as 18 mu daily for interferon-alpha and 600 mg daily for zidovudine. Variable changes in CD4 lymphocytes occurred during the first 8 weeks of therapy. At higher doses of the combination, sustained increases in median CD4 lymphocyte numbers were noted (p less than 0.001). In HIV antigenemic patients, progressive antigen suppression was seen with increasing doses of the combination (p less than 0.005). The overall antitumor response rate was 47%. Tumor regression was associated with better survival benefits (p less than 0.001) and a pretreatment CD4 cell count greater than or equal to 200 cells/mm3 (p = 0.01). In conclusion, intermediate doses of interferon-alpha and lower doses of zidovudine appear to be relatively well tolerated and associated with disease improvement, including survival benefits.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0894-9255
pubmed:author
pubmed:issnType
Print
pubmed:volume
4
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1-10
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:1670585-Acquired Immunodeficiency Syndrome, pubmed-meshheading:1670585-Adult, pubmed-meshheading:1670585-Anemia, pubmed-meshheading:1670585-Bisexuality, pubmed-meshheading:1670585-CD4-Positive T-Lymphocytes, pubmed-meshheading:1670585-Combined Modality Therapy, pubmed-meshheading:1670585-Drug Evaluation, pubmed-meshheading:1670585-Follow-Up Studies, pubmed-meshheading:1670585-HIV Antigens, pubmed-meshheading:1670585-HIV-1, pubmed-meshheading:1670585-Homosexuality, pubmed-meshheading:1670585-Humans, pubmed-meshheading:1670585-Injections, Intramuscular, pubmed-meshheading:1670585-Interferon Type I, pubmed-meshheading:1670585-Interferon-alpha, pubmed-meshheading:1670585-Leukocyte Count, pubmed-meshheading:1670585-Liver, pubmed-meshheading:1670585-Male, pubmed-meshheading:1670585-Neutropenia, pubmed-meshheading:1670585-Opportunistic Infections, pubmed-meshheading:1670585-Recombinant Proteins, pubmed-meshheading:1670585-Sarcoma, Kaposi, pubmed-meshheading:1670585-Zidovudine
pubmed:year
1991
pubmed:articleTitle
A phase I study of recombinant human interferon-alpha 2a or human lymphoblastoid interferon-alpha n1 and concomitant zidovudine in patients with AIDS-related Kaposi's sarcoma.
pubmed:affiliation
Department of Medicine, University of Miami School of Medicine, Florida 33101.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, U.S. Gov't, P.H.S., Randomized Controlled Trial