Efficacy and tolerability of 10-day monotherapy with apricitabine in antiretroviral-naive, HIV-infected patients

AIDS

Volumn 20, Issue 9, 2006, Pages 1261-1268

  Cahn, Pedro ^a   Cassetti, Isabel ^b   Wood, Robin ^c   Phanuphak, Praphan ^d   Shiveley, LeeAnn ^e   Bethell, Richard C ^f   Sawyer, James ^g  

^a FUNDACIÓN HUÉSPED   (Argentina)

^b Helios Salud ^*  (Argentina)

^c UNIVERSITY OF CAPE TOWN   (South Africa)

^d THAI RED CROSS AIDS RESEARCH CENTRE   (Thailand)

^e SHIRE   (United States)

^f Shire Canada   (Canada)

^g Prism Ideas   (United Kingdom)

Author keywords

Anti retroviral agents; Apricitabine; AVX754; HIV 1 reverse transcriptase; Reverse transcriptase inhibitors; SPD754

Indexed keywords

ALANINE AMINOTRANSFERASE; AMYLASE; APRICITABINE; ASPARTATE AMINOTRANSFERASE; CD4 ANTIGEN; CD8 ANTIGEN; CREATININE; PLACEBO; RNA DIRECTED DNA POLYMERASE INHIBITOR; SODIUM; TRIACYLGLYCEROL LIPASE; UNCLASSIFIED DRUG; VIRUS RNA;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMYLASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUTATION; MYALGIA; NOSE CONGESTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SODIUM BLOOD LEVEL; STATISTICAL SIGNIFICANCE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VIRUS LOAD;

ADMINISTRATION, ORAL; ADULT; ARGENTINA; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LYMPHOCYTE COUNT; MALE; MUTATION; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; SOUTH AFRICA; THAILAND; VIRAL LOAD;

EID: 33745869106     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.aids.0000232233.41877.63     Document Type: Article

References (18)

1. Wainberg MA, Sawyer JP, Montaner JS, Murphy RL, Kuritzkes DR, Raffi F. Challenges for the clinical development of new nucleoside reverse transcriptase inhibitors for HIV infection. Antivir Ther 2005; 10:13-28.
2. Gu Z, Allard B, de Muys JM, Lippens J, Rando RF, Nguyen-Ba N, et al. The in vitro antiretroviral activity and in vitro toxicity profile of SPD754, a new deoxycytidine nucleoside reverse transcriptase inhibitor for the treatment of HIV infection. Antimicrob Agents Chemother 2006; 50:625-631.
3. Bethell R, Adams J, De Muys J, Lippens J, Richard A, Hamelin B, et al. Pharmacological evaluation of a dual deoxycytidine analogue combination: 3TC and SPD754. Eleventh Conference on Retroviruses and Opportunistic Infections. San Francisco, February 2004 [abstract 138].
4. Bethell RC, Lie YS, Parkin NT. In vitro activity of SPD754, a new deoxycytidine nucleoside reverse transcriptase inhibitor (NRTI), against 215 HIV-1 isolates resistant to other NRTIs. Antivir Chem Chemother 2005; 16:295-302.
5. Francis RJ, Lanclos L, Shiveley L, Sawyer J. Pharmacokinetics (PK) of SPD754, a new cytidine analogue, in healthy volunteers. Antiviral Ther 2003; 8 (Suppl 1):S325.
6. De Muys J-M, Gourdeau H, Nguyen-Ba N, Taylor DL, Ahmed PS, Mansour T, et al. Anti-human immunodeficiency virus type 1 activity, intracellular metabolism and pharmacokinetics evaluation of 2′-deoxy-3′-oxa-4′- thiocytidine. Antimicrob Agents Chemother 1999; 43:1835-1844.
7. Taylor DL, Ahmed PS, Tyms SA, Wood LJ, Kelly LA, Chambers P, et al. Drug resistance and drug combination features of the human immunodeficiency virus inhibitor, BCH-10652 ((±)-2′-deoxy-3′-oxa-4′- thiocytidine, dOTC). Antiviral Chem Chemother 2000; 11:291-301.
8. Wood R, Trope B, Van Leeuwen RW, Martin DE, Proulx L. Potent antiretroviral activity of dOTC (BCH-10652) in HIV-infected patients: initial results from a phase I/II clinical trial. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, September 1999 [abstract 503].
9. Anonymous. From the Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. JAMA 1993; 269:729-730.
10. Louie M, Hogan C, Hurley A, Simon V, Chung C, Padte N. Determining the antiviral activity of tenofovir disoproxil fumarate in treatment naive chronically infected individuals. AIDS 2003; 17:1151-1156.
11. Rousseau FS. Prospective randomized trial of emtricitabine versus lamivudine short-term monotherapy in human immunodeficiency virus-infected patients. J Infect Dis 2003; 188:1652-1658.
12. Dunkle LM, Gathe JC, Pedevillano DE, Robinson HG, Rice WG, Pottage JC, et al. Elvucitabine: potent antiviral activity demonstrated in multi-drug resistant HIV infection [abstract 2]. Antiviral Ther 2003; 8:S5.
13. Salomon H, Wainberg MA, Brenner B, Quan Y, Rouleau D, Cote P, et al. Prevalence of HIV-1 resistant to antiretroviral drugs in 81 individuals newly infected by sexual contact or injecting drug use. Investigators of the Quebec Primary Infection Study. AIDS 2000; 14:F17-F23.
14. UK Collaborative Group on Monitoring the Transmission of HIV Drug Resistance. Analysis of prevalence of HIV-1 drug resistance in primary infections in the United Kingdom. BMJ 2001; 322:1087-1088.
15. Grant RM, Hecht FM, Warmerdam M, Liu L, Liegler T, Petropoulos CJ, et al. Time trends in primary HIV-1 drug resistance among recently infected persons. JAMA 2002; 288:181-188.
16. Little SJ, Holte S, Routy JP, Daar ES, Markowitz M, Collier AC, et al. Antiretroviral-drug resistance among patients recently infected with HIV. N Engl J Med 2002; 347:385-394.
17. Oette M, Kaiser R, Daumer M, Akbari D, Fatkenheuer G, Rockstroh JK, et al. Primary drug-resistance in HIV-positive patients on initiation of first-line antiretroviral therapy in Germany. Eur J Med Res 2004; 9:273-278.
18. Adams J, Sawyer J, Shiveley L. Intracellular SPD754 triphosphate pharmacokinetics following administration of SPD754 capsules. Eleventh Conference on Retroviruses and Opportunistic Infections. San Francisco, February 2004 [abstract 599].