Abstract
A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34%, according to a general estimating equation analysis, 92%, according to an observed data analysis, and 24%, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31%, 85%, and 22%, respectively. Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension.
| Original language | English |
|---|---|
| Pages (from-to) | 1119-1124 |
| Number of pages | 6 |
| Journal | Clinical Infectious Diseases |
| Volume | 37 |
| Issue number | 8 |
| DOIs | |
| State | Published - Oct 15 2003 |
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ASJC Scopus subject areas
- Immunology
Cite this
Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection. / Hirsch, Martin S.; Steigbigel, Roy T.; Staszewski, Scholomo; McMahon, Deborah; Fischl, Margaret A; Hirschel, Bernard; Squires, Kathleen; DiNubile, Mark J.; Harvey, Charlotte M.; Chen, Joshua; Leavitt, Randi Y.
In: Clinical Infectious Diseases, Vol. 37, No. 8, 15.10.2003, p. 1119-1124.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Long-Term Efficacy, Safety, and Tolerability of Indinavir-Based Therapy in Protease Inhibitor-Naive Adults with Advanced HIV Infection
AU - Hirsch, Martin S.
AU - Steigbigel, Roy T.
AU - Staszewski, Scholomo
AU - McMahon, Deborah
AU - Fischl, Margaret A
AU - Hirschel, Bernard
AU - Squires, Kathleen
AU - DiNubile, Mark J.
AU - Harvey, Charlotte M.
AU - Chen, Joshua
AU - Leavitt, Randi Y.
PY - 2003/10/15
Y1 - 2003/10/15
N2 - A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34%, according to a general estimating equation analysis, 92%, according to an observed data analysis, and 24%, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31%, 85%, and 22%, respectively. Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension.
AB - A double-blind, randomized study of zidovudine-experienced, PI- and lamivudine-naive adults with baseline CD4 cell counts of ≤50 cells/mm 3 had demonstrated that the HIV suppression achieved with zidovudine, lamivudine, and indinavir therapy was superior to that achieved with dualnucleoside or indinavir-only regimens after 24 weeks of therapy. In a 192-week extension of the study, 371 participants received open-label indinavir with or without other antiretroviral drugs. One hundred and eight subjects were originally randomized to receive triple therapy. After 216 weeks, the proportion of subjects with HIV RNA levels of <500 copies/ mL were 34%, according to a general estimating equation analysis, 92%, according to an observed data analysis, and 24%, according to an intention-to-treat analysis counting noncompleters as failures; the proportions of subjects with HIV RNA levels of <50 copies/mL were 31%, 85%, and 22%, respectively. Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension.
UR - http://www.scopus.com/inward/record.url?scp=0142156151&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0142156151&partnerID=8YFLogxK
U2 - 10.1086/378063
DO - 10.1086/378063
M3 - Article
C2 - 14523778
AN - SCOPUS:0142156151
VL - 37
SP - 1119
EP - 1124
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 8
ER -