Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial

The Lancet

Volumn 371, Issue 9630, 2008, Pages 2109-2119

  Celum, Connie ^a   Wald, Anna ^a,b   Hughes, James ^a   Sanchez, Jorge ^c   Reid, Stewart ^d,e   Delany Moretlwe, Sinead ^f   Cowan, Frances ^g   Casapia, Martin ^c   Ortiz, Abner ^c   Fuchs, Jonathan ^h   Buchbinder, Susan ^h   Koblin, Beryl ⁱ   Zwerski, Sheryl ^j   Rose, Scott ^k   Wang, Jing ^b   Corey, Lawrence ^a,b  

^a UNIVERSITY OF WASHINGTON   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c ASOCIACIÓN CIVIL IMPACTA SALUD Y EDUCACIÓN   (Peru)

^d University of Alabama at Birmingham   (United States)

^e Centre for Infectious Disease Research   (Zambia)

^f UNIVERSITY OF THE WITWATERSRAND   (South Africa)

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

^h SAN FRANCISCO DEPARTMENT OF PUBLIC HEALTH   (United States)

ⁱ NEW YORK BLOOD CENTER   (United States)

^j NATIONAL INSTITUTES OF HEALTH   (United States)

^k FAMILY HEALTH INTERNATIONAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; PLACEBO;

ADOLESCENT; ADULT; AGED; ARTICLE; BRAIN HEMORRHAGE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; EXAMINATION; FEMALE; FOLLOW UP; GENITAL ULCER; HAZARD RATIO; HERPES SIMPLEX; HERPES SIMPLEX VIRUS 2; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; INCIDENCE; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PATIENT COUNSELING; PERU; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; REGISTER; RISK FACTOR; RISK REDUCTION; SELF REPORT; SEPSIS; SERODIAGNOSIS; UNITED STATES; UNSPECIFIED SIDE EFFECT;

EID: 45249108765     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(08)60920-4     Document Type: Article

References (31)

1. Weiss H. Epidemiology of herpes simplex virus type 2 infection in the developing world. Herpes 11 suppl 1 (2004) 24A-35A
2. Lama J., Lucchetti A., Suarez L., et al. Association of herpes simplex virus type 2 infection and syphilis with human immunodeficiency virus infection among men who have sex with men in Peru. J Infect Dis 194 (2006) 1459-1466
3. Wald A., Zeh J., Selke S., et al. Reactivation of genital herpes simplex virus type 2 infection in asymptomatic seropositive persons. N Engl J Med 342 (2000) 844-850
4. Freeman E., Weiss H., Glynn J., Cross P., Whitworth J., and Hayes R. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS 20 (2006) 73-83
5. Wald A., and Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis 185 (2002) 45-52
6. Reynolds S., Risbud A., Shepherd M., et al. Recent herpes simplex virus type 2 infection and the risk of human immunodeficiency virus type 1 acquisition in India. J Infect Dis 187 (2003) 1513-1521
7. Brown E., Wald A., Hughes J., et al. High risk of human immunodeficiency virus in men who have sex with men with herpes simplex virus type 2 in the EXPLORE study. Am J Epidemiol 164 (2006) 733-741
8. Rebbapragada A., Wachihi C., Pettengell C., et al. Negative mucosal synergy between Herpes simplex type 2 and HIV in the female genital tract. AIDS 21 (2007) 589-598
9. Gray R., Wawer M., Brookmeyer R., et al. Probability of HIV-1 transmission per coital act in monogamous, heterosexual, HIV-1-discordant couples in Rakai, Uganda. Lancet 357 (2001) 1149-1153
10. Ioannidis J., Collier A., Cooper D., et al. Clinical efficacy of high-dose acyclovir in patients with human immunodeficiency virus infection: a meta-analysis of randomized individual patient data. J Infect Dis 178 (1998) 349-359
11. Mosca J., Bednarik D., Raj N., et al. Herpes simplex virus type-1 can reactivate transcription of latent human immunodeficiency virus. Nature 325 (1987) 67-70
12. Watson-Jones D., Weiss H., Rusizoka M., et al. Effect of Herpes Simplex Suppression on Incidence of HIV among Women in Tanzania. N Engl J Med 358 (2008) 1560-1571
13. Centers for Disease Control and Prevention, Workowski K., and Berman S. Sexually transmitted disease treatment guidelines. MMWR Recomm Rep 55 (2006) 18
14. Laeyendecker O., Henson C., Gray R., et al. Performance of a commercial, type-specific enzyme-linked immunosorbent assay for detection of herpes simplex virus type 2-specific antibodies in Ugandans. J Clin Microbiol 42 (2004) 1794-1796
15. Golden M., Ashley-Morrow R., Swenson P., Hogrefe W., Handsfield H., and Wald A. Herpes simplex virus type 2 (HSV-2) Western blot confirmatory testing among men testing positive for HSV-2 using the focus enzyme-linked immunosorbent assay in a sexually transmitted disease clinic. Sex Transm Dis 32 (2005) 771-777
16. Ashley R., Militoni J., Lee F., Nahmias A., and Corey L. Comparison of Western blot (immunoblot) and glycoprotein G-specific immunodot enzyme assay for detecting antibodies to herpes simplex virus types 1 and 2 in human sera. J Clin Microbiol 26 (1988) 662-667
17. Jerome K., Huang M., Wald A., Selke S., and Corey L. Quantitative stability of DNA after extended storage of clinical specimens as determined by real-time PCR. J Clin Microbiol 40 (2002) 2609-2611
18. Wald A., Huang M., Carrell D., and Corey L. Polymerase chain reaction for detection of herpes simplex virus (HSV) DNA on mucosal surfaces: comparison with HSV isolation in cell culture. J Infect Dis 188 (2003) 1345-1351
19. Nugent R., Krohn M., and Hillier S. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 2 (1991) 297-301
20. Mertz G., Jones C., Mills J., et al. Long-term acyclovir suppression of frequently recurring genital herpes simplex virus infection. A multicenter double-blind trial. JAMA 260 (1988) 201-206
21. Lan K., Gordan K., and DeMets D. Discrete sequential boundaries for clinical trials. Biometrika 70 (1983) 659-663
22. O'Brien P., and Fleming T. A multiple testing procedure for clinical trials. Biometrics 35 (1979) 549-556
23. Reitano M., Tyring S., Lang W., et al. Valaciclovir for the suppression of recurrent genital herpes simplex virus infection: a large-scale dose range-finding study. International Valaciclovir HSV Study Group. J Infect Dis 178 (1998) 603-610
24. Gupta R., Wald A., Krantz E., et al. Valacyclovir and acyclovir for suppression of shedding of herpes simplex virus in the genital tract. J Infect Dis 190 (2004) 1374-1381
25. Corey L., Wald A., Celum C., and Quinn T. The effects of herpes simplex virus-2 on HIV-1 acquisition and transmission: a review of two overlapping epidemics. J Acquir Immune Defic Syndr 35 (2004) 435-445
26. Nagot N., Ouedraogo A., Foulongne V., et al. Reduction of HIV-1 RNA levels with therapy to suppress herpes simplex virus. N Engl J Med 356 (2007) 790-799
27. Zuckerman R., Lucchetti A., Whittington W., et al. Herpes simplex virus (HSV) suppression with valacyclovir reduces rectal and blood plasma HIV-1 levels in HIV-1/HSV-2-seropositive men: a randomized, double-blind, placebo-controlled crossover trial. J Infect Dis 196 (2007) 1500-1508
28. Delany S, Mayaud P, Clayton T, et al. Impact of HSV-2 suppressive therapy on genital and plasma HIV-1 RNA in HIV-1 and HSV-2-seropostive women not taking ART: a randomized, placebo-controlled trial in Johannesburg, South Africa. 14th Conference on Retroviruses and Opportunistic Infections; Los Angeles, CA, USA. Foundation for Retrovirology and Human Health, 2007: 123 (abstract number 154LB).
29. Dunne E., Whitehead S., Sternberg M., et al. The effect of suppressive acyclovir therapy on HIV cervicovaginal shedding in HIV- and HSV-2-infected women, Chiang Rai, Thailand. 14th Conference on Retroviruses and Opportunistic Infections (2007), Foundation for Retrovirology and Human Health, Los Angeles, CA, USA 75 (abstract number 30).
30. Baeten J, Strick L, Lucchetti, et al. Herpes simplex virus suppressive treatment decreases plasma HIV-1 viral load in HSV-2/HIV-1 co-infected women: a randomized, placebo-controlled, cross-over trial. 15th Conference on Retroviruses and Opportunistic Infections; Boston, MA, USA, 2008: 311 (abstract number 676).
31. Ouedraogo A., Nagot N., Vergne L., et al. Impact of suppressive herpes therapy on genital HIV-1 RNA among women taking antiretroviral therapy: a randomized controlled trial. AIDS 20 (2006) 2305-2313