Clinical trial NCT00808405: GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Official title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Herpes
Keywords: herpes simplex virus
acyclovir
HSV shedding
women
Africa
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institutes of Health (NIH)
First posted: 2008-12-15
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Healing of Genital Lesions
timeFrame: Days 1-5, 7, 9, 11, 13
Secondary outcomes:
measure: Time to First Negative Herpes Simplex Virus (HSV) DNA PCR
timeFrame: Days 1-5, 7, 9, 11, 13
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Reproductive Health and HIV Research Unit (RHRU)
city: Lusaka
country: Zambia
facility: Center for Infectious Disease Research of Zambia (CIDRZ)
Study officials:
affiliation: University of Washington
name: Connie Celum, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Anna Wald, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey L, Wald A, Celum C. Clinical and virologic response to episodic acyclovir for genital ulcers among HIV-1 seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-controlled trial. Sex Transm Dis. 2012 Jan;39(1):21-4. doi: 10.1097/OLQ.0b013e31823b50c6.