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A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

Primary Purpose

HIV Infections, HIV Seronegativity, Herpes Genitalis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acyclovir
Acyclovir placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria For All Participants: 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 Inclusion Criteria for MSM: At least 1 episode of anal intercourse with another man within 6 months of study entry Inclusion Criteria for WSM: At least 1 episode of unprotected vaginal sex within 6 months of study entry Exclusion Criteria For All Participants: 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 Exclusion Criteria for MSM: In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years Reported sex at birth as female Exclusion Criteria for WSM: Pregnancy at screening or enrollment

Sites / Locations

  • San Francisco Department of Public Health, AIDS Office, Research Section
  • New York Blood Center
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Participants will receive acyclovir for the duration of the study

Participants will receive acyclovir placebo for the duration of the trial

Outcomes

Primary Outcome Measures

Serologically confirmed HIV infection

Secondary Outcome Measures

Occurrence and frequency of genital ulcers
Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo

Full Information

First Posted
January 15, 2004
Last Updated
December 29, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00076232
Brief Title
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.
Detailed Description
Many studies have shown that prior HSV-2 infection is associated with an increased risk for HIV infection. Acyclovir is the most widely studied and clinically utilized antiviral for the suppression of HSV-2 infection. This study will evaluate the efficacy of twice-daily dosing of acyclovir in preventing HIV infection in both WSM and MSM with genital herpes. For this study, WSM will be enrolled in Lusaka, Zambia; Harare, Zimbabwe; and Johannesburg, South Africa; MSM will be enrolled in Lima and Pucallpa, Peru; Seattle, Washington, USA; New York City, New York, USA; and San Francisco, California, USA. Participants will be enrolled for 12 months in this study and will be randomly assigned to one of two study arms. The first arm will receive 400 mg acyclovir twice daily; the second arm will receive placebo. Follow-up visits will occur monthly. Participants will be tested for STDs, including HIV and syphilis, at each visit and treated as necessary; participants will also be given adherence and condom counseling, risk behavior and sexual history questionnaires, and genital symptoms questionnaires at all study visits. Medical history will be assessed and participants will undergo blood work at Months 3, 6, 9, and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity, Herpes Genitalis
Keywords
HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
3682 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive acyclovir for the duration of the study
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive acyclovir placebo for the duration of the trial
Intervention Type
Drug
Intervention Name(s)
Acyclovir
Intervention Description
400 mg tablet taken orally twice daily
Intervention Type
Drug
Intervention Name(s)
Acyclovir placebo
Intervention Description
Oral tablet taken twice daily
Primary Outcome Measure Information:
Title
Serologically confirmed HIV infection
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Occurrence and frequency of genital ulcers
Time Frame
Throughout study
Title
Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo
Time Frame
Throughout study

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria For All Participants: 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 Inclusion Criteria for MSM: At least 1 episode of anal intercourse with another man within 6 months of study entry Inclusion Criteria for WSM: At least 1 episode of unprotected vaginal sex within 6 months of study entry Exclusion Criteria For All Participants: 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 Exclusion Criteria for MSM: In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years Reported sex at birth as female Exclusion Criteria for WSM: Pregnancy at screening or enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Celum, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna Wald, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco Department of Public Health, AIDS Office, Research Section
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
New York Blood Center
City
New York City
State/Province
New York
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12844451
Citation
Bruisten SM. Genital ulcers in women. Curr Womens Health Rep. 2003 Aug;3(4):288-98.
Results Reference
background
PubMed Identifier
12667248
Citation
Mbopi-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.
Results Reference
background
PubMed Identifier
11867018
Citation
Schacker T. The role of HSV in the transmission and progression of HIV. Herpes. 2001 Jul;8(2):46-9.
Results Reference
background
PubMed Identifier
11756980
Citation
Wald 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.
Results Reference
background
PubMed Identifier
18572080
Citation
Celum 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.
Results Reference
result
PubMed Identifier
19838129
Citation
Reid 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.
Results Reference
result
PubMed Identifier
20702659
Citation
Watson-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.
Results Reference
result
PubMed Identifier
21150554
Citation
Curlin 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.
Results Reference
result
PubMed Identifier
21104007
Citation
Jacob 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.
Results Reference
result
PubMed Identifier
21099672
Citation
Sanchez 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.
Results Reference
result
PubMed Identifier
20214474
Citation
Fuchs 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.
Results Reference
derived

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A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

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