Definition of loss of virological response in trials of antiretroviral drugs

AIDS

Volumn 17, Issue 13, 2003, Pages 1997-1998

  Staszewski, Schlomo ^a   Sabin, Caroline ^b   Dauer, Brenda ^a   Cozzi Lepri, Alessandro ^b   Phillips, Andrew ^b  

^a GOETHE UNIVERSITY   (Germany)

^b ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; NUCLEOSIDE ANALOG;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; FOOD AND DRUG ADMINISTRATION; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; TREATMENT OUTCOME; VIRUS INFECTION; VIRUS LOAD;

EID: 0041827351     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-200309050-00024     Document Type: Article

References (5)

1. US Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for industry. Antiretroviral drugs using plasma HIV RNA measurements - clinical considerations for accelerated and traditional approval. http://www.fda.gov/cder/guidance/index.htm. October 2002.
2. Havlir DV, Bassett R, Levitan D, Gilbert P, Tegas P, Collier AC, et al. Prevalence and predictive value of intermittent viremia with combination HIV therapy. JAMA 2001, 286:171-179.
3. Greub G, Cozzi-Lepri A, Ledergerber B, Staszewski S, Perrin L, Miller V, et al. Intermittent and sustained low-level HIV viral reboundund in patients receiving potent antiretroviral therapy. AIDS 2002, 16:1967-1969.
4. Moore AL, Youle M, Lipman M, Cozzi-Lepri A, Lampe F, Madge S, et al. Raised viral load in patients with viral suppression on highly active antiretroviral therapy: transient increase or treatment failure? AIDS 2002, 16:615-618.
5. Sklar PA, Ward DJ, Baker RK, Wood KC, Gafoor Z, Alzola CF, et al. Prevalence and clinical correlates of HIV viremia ('blips') in patients with previous suppression below the limits of quantification. AIDS 2002, 16:2035-2041.