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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
2
|
| pubmed:dateCreated |
1994-3-4
|
| pubmed:abstractText |
We conducted a double-blind, randomized phase II study to evaluate the safety and activity of combination therapy with N-butyl-deoxynojirimycin (SC-48334) (an alpha-glucosidase I inhibitor) and zidovudine versus zidovudine alone. Patients with 200 to 500 CD4 cells/mm3 who tolerated < or = 12 weeks of prior zidovudine therapy received SC-48334 (1000 mg every 8 h) and zidovudine (100 mg every 8 h) or zidovudine and placebo. Sixty patients received combination therapy and 58, zidovudine and placebo. Twenty-three patients (38%) and 15 (26%), in the combination and zidovudine groups, respectively, discontinued therapy (p = 0.15). The mean SC-48334 steady-state trough level (4.04 +/- 0.99 micrograms/ml) was below the in vitro inhibitory concentration for human immunodeficiency virus (HIV). The mean increase in CD4 cells at week 4 was 73.8 cells/mm3 and 52.4 cells/mm3 for the combination and zidovudine groups, respectively (p > 0.36). For patients with prior zidovudine therapy, the mean change in CD4 cells in the combination and zidovudine groups was 63.7 cells/mm3 and 4.9 cells/mm3 at week 8 and 6.8 cells/mm3 and -45.1 cells/mm3 at week 16, respectively. The number of patients with suppression of HIV p24 antigenemia in the combination and zidovudine groups was six (40%) and two (11%) at week 4 (p = 0.10) and five (45%) and two (14%) at week 24 (p = 0.08), respectively. Diarrhea, flatulence, abdominal pain, and weight loss were common for combination recipients.(ABSTRACT TRUNCATED AT 250 WORDS)
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/1-Deoxynojirimycin,
http://linkedlifedata.com/resource/pubmed/chemical/Antiviral Agents,
http://linkedlifedata.com/resource/pubmed/chemical/HIV Core Protein p24,
http://linkedlifedata.com/resource/pubmed/chemical/Hemoglobins,
http://linkedlifedata.com/resource/pubmed/chemical/RNA, Viral,
http://linkedlifedata.com/resource/pubmed/chemical/Zidovudine,
http://linkedlifedata.com/resource/pubmed/chemical/beta 2-Microglobulin,
http://linkedlifedata.com/resource/pubmed/chemical/miglustat
|
| pubmed:status |
MEDLINE
|
| pubmed:month |
Feb
|
| pubmed:issn |
0894-9255
|
| pubmed:author | |
| pubmed:issnType |
Print
|
| pubmed:volume |
7
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
N
|
| pubmed:pagination |
139-47
|
| pubmed:dateRevised |
2006-11-15
|
| pubmed:meshHeading |
pubmed-meshheading:7905523-1-Deoxynojirimycin,
pubmed-meshheading:7905523-Adult,
pubmed-meshheading:7905523-Antiviral Agents,
pubmed-meshheading:7905523-CD4-Positive T-Lymphocytes,
pubmed-meshheading:7905523-Diarrhea,
pubmed-meshheading:7905523-Double-Blind Method,
pubmed-meshheading:7905523-Drug Therapy, Combination,
pubmed-meshheading:7905523-Female,
pubmed-meshheading:7905523-Follow-Up Studies,
pubmed-meshheading:7905523-HIV Core Protein p24,
pubmed-meshheading:7905523-HIV Infections,
pubmed-meshheading:7905523-HIV-1,
pubmed-meshheading:7905523-Hemoglobins,
pubmed-meshheading:7905523-Humans,
pubmed-meshheading:7905523-Leukocyte Count,
pubmed-meshheading:7905523-Male,
pubmed-meshheading:7905523-Neutrophils,
pubmed-meshheading:7905523-Paresthesia,
pubmed-meshheading:7905523-RNA, Viral,
pubmed-meshheading:7905523-Zidovudine,
pubmed-meshheading:7905523-beta 2-Microglobulin
|
| pubmed:year |
1994
|
| pubmed:articleTitle |
The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3.
|
| pubmed:affiliation |
University of Miami School of Medicine, Florida.
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase II
|