ASP2151 for the treatment of genital herpes: A randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study

Journal of Infectious Diseases

Volumn 205, Issue 7, 2012, Pages 1100-1110

  Tyring, Stephen ^a   Wald, Anna ^b   Zadeikis, Neddie ^c   Dhadda, Shobha ^c   Takenouchi, Kazumasa ^c   Rorig, Ramona ^c  

^a University of Texas Health Science Center at Houston   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c Astellas Pharma Global Development   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; AMENAMEVIR; PLACEBO; VALACICLOVIR;

ABDOMINAL PAIN; ADULT; ANTIVIRAL ACTIVITY; ANTIVIRAL RESISTANCE; ANTIVIRAL THERAPY; ARTHRALGIA; ARTICLE; BACKACHE; CLINICAL FEATURE; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOSE CALCULATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; GENITAL HERPES; HEADACHE; HERPES SIMPLEX VIRUS; HUMAN; IC 50; INFLUENZA; LETHARGY; MAJOR CLINICAL STUDY; MALE; NAUSEA; NONHUMAN; OUTCOME ASSESSMENT; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT INFECTION; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; TACHYCARDIA; TREMOR; VIRUS CULTURE; VIRUS IDENTIFICATION; VIRUS ISOLATION; VOMITING; XEROSTOMIA;

ACYCLOVIR; ADULT; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; FEMALE; HERPES GENITALIS; HUMANS; MALE; MIDDLE AGED; OXADIAZOLES; PLACEBOS; TREATMENT OUTCOME; VALINE;

EID: 84858162396     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jis019     Document Type: Article

References (18)

1. Morfin F, Thouvenot D. Herpes simplex virus resistance to antiviral drugs. J Clin Virol 2003; 26:29-37. (Pubitemid 36183346)
2. Reyes M, Shaik NS, Graber JM, et al. Acyclovir-resistant genital herpes among persons attending sexually transmitted disease and human immunodeficiency virus clinics. Arch Intern Med 2003; 163:76-80. (Pubitemid 36091604)
3. Corey L, Wald A, Patel R, et al. Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N Engl J Med 2004; 350:11-20. (Pubitemid 38032179)
4. Chono K, Katsumata K, Kontani T, et al. ASP2151, a novel hesicase-primase inhibitor, is an antivirus candidate for infections of varicellazoster virus and herpes simplex virus types 1 and 2. J Antimicrob Chemother 2010; 65:1733-41.
5. Bodsworth NJ, Crooks RJ, Borelli S, et al. Valaciclovir versus aciclovir in patient initiated treatment of recurrent genital herpes: a randomised, double blind clinical trial. International Valaciclovir HSV Study Group. Genitourin Med 1997; 73:110-6. (Pubitemid 27204852)
6. Tyring SK, Douglas JM Jr, Corey L, Spruance SL, Esmann J. A randomized, placebo-controlled comparison of oral valacyclovir and acyclovir in immunocompetent patients with recurrent genital herpes infections. The Valaciclovir International Study Group. Arch Dermatol 1998; 134:185-91. (Pubitemid 28119669)
7. Reichman RC, Badger GJ, Mertz GJ, et al. Treatment of recurrent genital herpes simplex infections with oral acyclovir. A controlled trial. JAMA 1984; 251:2103-7. (Pubitemid 14133504)
8. Sacks SL, Aoki FY, Diaz-Mitoma F, Sellors J, Shafran SD. Patient-initiated, twice-daily oral famciclovir for early recurrent genital herpes. A randomized, double-blind multicenter trial. Canadian Famciclovir Study Group. JAMA 1996; 276:44-9. (Pubitemid 26231055)
9. Spruance SL, Tyring SK, DeGregorio B, Miller C, Beutner K. A large-scale, placebo-controlled, dose-ranging trial of peroral valaciclovir for episodic treatment of recurrent herpes genitalis. Valaciclovir HSV Study Group. Arch Intern Med 1996; 156:1729-35. (Pubitemid 26287131)
10. Brantley JS, Hicks L, Sra K, Tyring SK. Valacyclovir for the treatment of genital herpes. Expert Rev Anti Infect Ther 2006; 4:367-76. (Pubitemid 43905459)
11. Vinh DC, Aoki FY. Famciclovir for the treatment of recurrent genital herpes: a clinical and pharmacological perspective. Expert Opin Pharmacother 2006; 7:2271-86.
12. Aoki FY, Tyring S, Diaz-Mitoma F, Gross G, Gao J, Hamed K. Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis 2006; 42:8-13. (Pubitemid 41832073)
13. Mertz GJ, Critchlow CW, Benedetti J, et al. Double-blind placebo-controlled trial of oral acyclovir in first-episode genital herpes simplex virus infection. JAMA 1984; 252:1147-51. (Pubitemid 14067513)
14. Wald A, Carrell D, Remington M, Kexel E, Zeh J, Corey L. Two-day regimen of acyclovir for treatment of recurrent genital herpes simplex virus type 2 infection. Clin Infect Dis 2002; 34:944-8. (Pubitemid 34229763)
15. Leone PA, Trottier S, Miller JM. Valacyclovir for episodic treatment of genital herpes: a shorter 3-day treatment course compared with 5-day treatment. Clin Infect Dis 2002; 34:958-62. (Pubitemid 34229765)
16. Saltzman R, Jurewicz R, Boon R. Safety of famciclovir in patients with herpes zoster and genital herpes. Antimicrob Agents Chemother 1994; 38:2454-7. (Pubitemid 24304247)
17. Tilson HH, Engle CR, Andrews EB. Safety of acyclovir: a summary of the first 10 years experience. J Med Virol 1993; Suppl 1):67-73.
18. Tyring SK, Baker D, Snowden W. Valacyclovir for herpes simplex virus infection: long-term safety and sustained efficacy after 20 years' experience with acyclovir. J Infect Dis 2002; 186(Suppl 1): S40-6. (Pubitemid 35178848)