GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

Genital Herpes Clinical Trial

— PK/GUD  

Official title:

Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808405
• Other study ID #: 34708-A
• Secondary ID: U01AI052054
• Status: Completed
• Phase: N/A
• First received: November 25, 2008
• Last updated: November 15, 2013
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• HIV negative as determined by concordant rapid testing

• HSV-2 seropositive (Focus HerpeSelect >3.4)

• At least one prior occurrence of GUD

• 18-50 years of age

Exclusion Criteria:

• Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir

• Prior hypersensitivity &/or allergic reaction to acyclovir

• Use of probenicid

• Current use, or use within past 28 days, of an investigational agent

• Currently pregnant or nursing

• Currently plan to become pregnant during next 3 months

• Any condition that will interfere with successful completion of study procedures

Related Conditions & MeSH terms

• Genital Herpes
• Herpes Genitalis

Intervention

Drug:
• acyclovir
400mg taken orally three times daily for 5 days
• matching placebo
matching placebo taken orally three times daily for 5 days.

Locations

Country	Name	City	State
South Africa	Reproductive Health and HIV Research Unit (RHRU)	Johannesburg
Zambia	Center for Infectious Disease Research of Zambia (CIDRZ)	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Countries where clinical trial is conducted

South Africa,  Zambia, 

References & Publications (2)

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. — View Citation

Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW. Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations. Antimicrob Agents Chemother. 2012 May;56(5):2777-9. doi: 10.1128/AAC.06160-11. Epub 2012 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Healing of Genital Lesions	To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo	Days 1-5, 7, 9, 11, 13
Secondary	Time to First Negative Herpes Simplex Virus (HSV) DNA PCR	To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo	Days 1-5, 7, 9, 11, 13