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Early Virologic Nonresponse to Tenofovir, Abacavir, and Lamivudine in HIVâInfected AntiretroviralâNaive Subjects
- Source :
- The Journal of Infectious Diseases. 192:1921-1930
- Publication Year :
- 2005
- Publisher :
- Oxford University Press (OUP), 2005.
-
Abstract
- BACKGROUND: Antiretroviral combinations that reduce the number of pills and dosing frequency have the potential to simplify therapy. We compared 2 regimens dosed as 2 pills once daily. METHODS: This was a randomized, open-label, multicenter study of tenofovir disoproxil fumarate versus efavirenz, both administered once daily with the abacavir/lamivudine fixed-dose combination in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected subjects. After reports of early nonresponse, an unplanned interim analysis was performed. Virologic nonresponse was defined as (1) a or =1.0 log(10) copies/mL above the nadir, or (3) for subjects with 2 consecutive HIV-1 RNA measurements 400 copies/mL on 2 consecutive occasions. RESULTS: We randomized 340 subjects. Median baseline HIV-1 RNA level and CD4+ cell count were 4.7 log(10) copies/mL and 251 cells/mm3, respectively; 194 subjects with HIV-1 RNA data from > or =8 weeks were included in the interim analysis. Virologic nonresponse occurred in 50 (49%) of 102 subjects in the tenofovir disoproxil fumarate arm, compared with 5 (5%) of 92 of subjects in the efavirenz arm (P
- Subjects :
- medicine.medical_specialty
Efavirenz
biology
business.industry
virus diseases
Lamivudine
Pharmacology
Resistance mutation
medicine.disease
biology.organism_classification
Interim analysis
Gastroenterology
chemistry.chemical_compound
Regimen
Infectious Diseases
Acquired immunodeficiency syndrome (AIDS)
chemistry
immune system diseases
Abacavir
Internal medicine
Immunology and Allergy
Medicine
business
Sida
medicine.drug
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 192
- Database :
- OpenAIRE
- Journal :
- The Journal of Infectious Diseases
- Accession number :
- edsair.doi...........177809c760e6a7e27738eb9e9790d9b0