Linked Life Data

12473836

Source:http://linkedlifedata.com/resource/pubmed/id/12473836

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2002-12-10
pubmed:abstractText
There is no standard treatment of HIV-infected patients who fail protease inhibitor (PI)-containing antiretroviral therapy. This open-label, noncomparative 24-week study with a 24-week extension evaluated the efficacy, safety, and tolerability of twice-daily indinavir/ritonavir 800/200 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) in this population. Presented here are the results of the 24-week study. Patients were HIV-infected adults who had prior viral RNA (vRNA) suppression (<400 copies/mL), subsequent failure (> or =400 and < or =100,000 copies/mL) on antiretroviral therapy, and at least one new NRTI available for treatment. The proportions of patients achieving plasma vRNA <400 and <50 copies/mL were analyzed with data as observed (DAO) and intention-to-treat (ITT) models using generalized estimating equations (GEE) or counting noncompleters as failures (NC = F). Mean changes from baseline in vRNA and CD4 cell count were evaluated using DAO and an ITT mixed-model approach. Sixty-three patients (87% male) with a mean age of 42 years and mean baseline vRNA and CD4 cell counts of 3.8 log(10) copies/mL and 360 cells/mm(3), respectively, were enrolled. The proportion (95% confidence interval) of patients achieving vRNA <400 and <50 copies/mL at week 24 were 76% (61%, 87%) and 50% (35%, 65%) for DAO, 64% (50%, 75%) and 43% (30%, 56%) for GEE, and 56% (43%, 68%) and 37% (25%, 50%) for NC = F, respectively. At Week 24, baseline vRNA decreased by >1.0 log(10) copies/mL and CD4 cell counts increased by approximately 90 cells/mm(3). Three patients (5%) experienced serious drug-related adverse events. Seven patients (11%) discontinued treatment due to clinical or laboratory adverse events. In this study, the enhanced, twice-daily regimen of indinavir/ritonavir 800/200 mg plus 2 NRTIs provided suppression of HIV in many patients who had failed a PI-containing regimen and was generally well tolerated.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
1525-4135
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
31
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
483-7
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:12473836-Acidosis, pubmed-meshheading:12473836-Adult, pubmed-meshheading:12473836-Anti-HIV Agents, pubmed-meshheading:12473836-CD4 Lymphocyte Count, pubmed-meshheading:12473836-Drug Administration Schedule, pubmed-meshheading:12473836-Drug Therapy, Combination, pubmed-meshheading:12473836-Female, pubmed-meshheading:12473836-HIV, pubmed-meshheading:12473836-HIV Infections, pubmed-meshheading:12473836-HIV Protease Inhibitors, pubmed-meshheading:12473836-Humans, pubmed-meshheading:12473836-Hyperbilirubinemia, pubmed-meshheading:12473836-Hypercholesterolemia, pubmed-meshheading:12473836-Hyperglycemia, pubmed-meshheading:12473836-Hypertriglyceridemia, pubmed-meshheading:12473836-Indinavir, pubmed-meshheading:12473836-Kidney Calculi, pubmed-meshheading:12473836-Male, pubmed-meshheading:12473836-Middle Aged, pubmed-meshheading:12473836-RNA, Viral, pubmed-meshheading:12473836-Ritonavir, pubmed-meshheading:12473836-Treatment Failure
pubmed:year
2002
pubmed:articleTitle
Open-label study of a twice-daily indinavir 800-mg/ritonavir 200-mg regimen in HIV-infected adults failing a protease inhibitor regimen.
pubmed:affiliation
Mercer University School of Medicine, Macon, Georgia, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Multicenter Study