Genital Herpes Clinical Trial
— PK/GUDOfficial title:
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
Verified date | November 2013 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Reproductive Health and HIV Research Unit (RHRU) | Johannesburg | |
Zambia | Center for Infectious Disease Research of Zambia (CIDRZ) | Lusaka |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
South Africa, Zambia,
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
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 |
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