A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals
4 other identifiers
interventional
3,682
1 country
3
Brief Summary
Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM). Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Apr 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2004
CompletedFirst Posted
Study publicly available on registry
January 16, 2004
CompletedStudy Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedDecember 30, 2010
August 1, 2009
2.2 years
January 15, 2004
December 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serologically confirmed HIV infection
Throughout study
Secondary Outcomes (2)
Occurrence and frequency of genital ulcers
Throughout study
Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo
Throughout study
Study Arms (2)
1
EXPERIMENTALParticipants will receive acyclovir for the duration of the study
2
PLACEBO COMPARATORParticipants will receive acyclovir placebo for the duration of the trial
Interventions
Eligibility Criteria
You may qualify if:
- HIV-uninfected
- HSV-2 infected
- Plans to stay in the area for the duration of study participation
- Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information
- At least 1 episode of anal intercourse with another man within 6 months of study entry
- At least 1 episode of unprotected vaginal sex within 6 months of study entry
You may not qualify if:
- Current enrollment in another HIV vaccine or prevention trial
- History of adverse reaction to acyclovir
- Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.
- Known plans for travel away from study site for more than 2 months
- In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years
- Reported sex at birth as female
- Pregnancy at screening or enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
San Francisco Department of Public Health, AIDS Office, Research Section
San Francisco, California, 94102, United States
New York Blood Center
New York, New York, United States
University of Washington
Seattle, Washington, 98104, United States
Related Publications (11)
Bruisten SM. Genital ulcers in women. Curr Womens Health Rep. 2003 Aug;3(4):288-98.
PMID: 12844451BACKGROUNDMbopi-Keou FX, Robinson NJ, Mayaud P, Belec L, Brown DW. Herpes simplex virus type 2 and heterosexual spread of human immunodeficiency virus infection in developing countries: hypotheses and research priorities. Clin Microbiol Infect. 2003 Mar;9(3):161-71. doi: 10.1046/j.1469-0691.2003.00550.x.
PMID: 12667248BACKGROUNDSchacker T. The role of HSV in the transmission and progression of HIV. Herpes. 2001 Jul;8(2):46-9.
PMID: 11867018BACKGROUNDWald A, Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis. 2002 Jan 1;185(1):45-52. doi: 10.1086/338231. Epub 2001 Dec 14.
PMID: 11756980BACKGROUNDCelum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L; HPTN 039 Protocol Team. 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. Lancet. 2008 Jun 21;371(9630):2109-19. doi: 10.1016/S0140-6736(08)60920-4.
PMID: 18572080RESULTReid SE, Dai JY, Wang J, Sichalwe BN, Akpomiemie G, Cowan FM, Delany-Moretlwe S, Baeten JM, Hughes JP, Wald A, Celum C. Pregnancy, contraceptive use, and HIV acquisition in HPTN 039: relevance for HIV prevention trials among African women. J Acquir Immune Defic Syndr. 2010 Apr;53(5):606-13. doi: 10.1097/QAI.0b013e3181bc4869.
PMID: 19838129RESULTWatson-Jones D, Wald A, Celum C, Lingappa J, Weiss HA, Changalucha J, Baisley K, Tanton C, Hayes RJ, Marshak JO, Gladden RG, Koelle DM. Use of acyclovir for suppression of human immunodeficiency virus infection is not associated with genotypic evidence of herpes simplex virus type 2 resistance to acyclovir: analysis of specimens from three phase III trials. J Clin Microbiol. 2010 Oct;48(10):3496-503. doi: 10.1128/JCM.01263-10. Epub 2010 Aug 11.
PMID: 20702659RESULTCurlin ME, Cassis-Ghavami F, Magaret AS, Spies GA, Duerr A, Celum CL, Sanchez JL, Margolick JB, Detels R, McElrath MJ, Corey L. Serological immunity to adenovirus serotype 5 is not associated with risk of HIV infection: a case-control study. AIDS. 2011 Jan 14;25(2):153-8. doi: 10.1097/QAD.0b013e328342115c.
PMID: 21150554RESULTJacob ST, Baeten JM, Hughes JP, Peinado J, Wang J, Sanchez J, Reid SE, Delany-Moretlwe S, Cowan F, Fuchs JD, Koblin B, Griffith S, Wald A, Celum C. A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial. AIDS Behav. 2011 Jul;15(5):897-904. doi: 10.1007/s10461-010-9853-2.
PMID: 21104007RESULTSanchez J, Sal Y Rosas VG, Hughes JP, Baeten JM, Fuchs J, Buchbinder SP, Koblin BA, Casapia M, Ortiz A, Celum C. Male circumcision and risk of HIV acquisition among MSM. AIDS. 2011 Feb 20;25(4):519-23. doi: 10.1097/QAD.0b013e328340fd81.
PMID: 21099672RESULTFuchs J, Celum C, Wang J, Hughes J, Sanchez J, Cowan F, Reid S, Delany-Moretlwe S, Corey L, Wald A; HIV Prevention Trials Network 039 Protocol Team. Clinical and virologic efficacy of herpes simplex virus type 2 suppression by acyclovir in a multicontinent clinical trial. J Infect Dis. 2010 Apr 15;201(8):1164-8. doi: 10.1086/651381.
PMID: 20214474DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Connie Celum, MD, MPH
University of Washington
- STUDY CHAIR
Anna Wald, MD, MPH
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 15, 2004
First Posted
January 16, 2004
Study Start
April 1, 2005
Primary Completion
June 1, 2007
Study Completion
November 1, 2007
Last Updated
December 30, 2010
Record last verified: 2009-08