Document Detail


Toxicity and drug exposure in a quadruple drug regimen in HIV-1 infected patients participating in the ADAM study.
MedLine Citation:
PMID:  10714568     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To study the relationship between toxicity and the exposure to nelfinavir and saquinavir as part of a quadruple drug regimen. DESIGN: The ADAM study is a randomized study to investigate the feasibility of induction-maintenance therapy in HIV-1 infection. METHODS: HIV-1-infected patients with no prior use of antiretroviral treatment started induction therapy consisting of stavudine + lamivudine + nelfinavir + saquinavir for a period of 26 weeks. Data regarding toxicity of the quadruple regimen and exposure to the protease inhibitors were collected. RESULTS: Seven of the 65 patients enrolled had to switch therapy for reasons of toxicity within the first 26 weeks. Diarrhoea was frequently reported (49 of 65, one discontinuation), but could be relieved by using antidiarrhoeal agents. Laboratory monitoring revealed elevated liver enzymes (leading to four discontinuations) and mild to moderate elevations of triglycerides and cholesterol (nine and 23 of 65, respectively). The exposure to saquinavir and nelfinavir was lower than expected. Abdominal pain was associated with a higher exposure to nelfinavir or saquinavir. The association of nausea and abdominal distension with drug exposure appeared to vary over time. CONCLUSIONS: The quadruple drug regimen was quite well tolerated. Diarrhoea was frequently reported but could be relieved by the use of antidiarrhoeal agents. In comparison with other protease inhibitor combinations, lipid abnormalities in plasma were infrequent and mild. With the exception of diarrhoea, all gastrointestinal complaints observed were found to be associated with the level of exposure to nelfinavir or saquinavir. The exposure to the protease inhibitors was relatively low, although the virologic efficacy of the regimen used was satisfactory.
Authors:
M H Reijers; H M Weigel; A A Hart; R W Ten Kate; J W Mulder; P Reiss; H Schuitemaker; R M Hoetelmans; G J Weverling; J M Lange
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  AIDS (London, England)     Volume:  14     ISSN:  0269-9370     ISO Abbreviation:  AIDS     Publication Date:  2000 Jan 
Date Detail:
Created Date:  2000-04-11     Completed Date:  2000-04-11     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  59-67     Citation Subset:  IM; X    
Affiliation:
National AIDS Therapy Evaluation Center, Department of Internal Medicine, Academic Medical Center, University of Amsterdam, The Netherlands.
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy*,  virology
Adult
Anti-HIV Agents / adverse effects*,  therapeutic use
CD4 Lymphocyte Count
Diarrhea / chemically induced
Drug Therapy, Combination
Female
HIV Protease Inhibitors / adverse effects,  therapeutic use
HIV-1* / drug effects
Humans
Lamivudine / adverse effects,  therapeutic use
Liver / drug effects,  enzymology
Male
Middle Aged
Nausea / chemically induced
Nelfinavir / adverse effects,  therapeutic use
Reverse Transcriptase Inhibitors / adverse effects,  therapeutic use
Saquinavir / adverse effects,  therapeutic use
Stavudine / adverse effects,  therapeutic use
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/HIV Protease Inhibitors; 0/Reverse Transcriptase Inhibitors; 127779-20-8/Saquinavir; 134678-17-4/Lamivudine; 159989-64-7/Nelfinavir; 3056-17-5/Stavudine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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