GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women (PK/GUD)

• ClinicalTrials.gov Identifier: NCT00808405
• Recruitment Status: Completed
• First Posted: December 15, 2008
• Results First Posted: May 18, 2012
• Last Update Posted: December 11, 2013
• Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Information provided by (Responsible Party): Connie Celum, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Genital Herpes	Drug: acyclovir; Drug: matching placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
• Study Start Date: January 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: acyclovir	Drug: acyclovir; 400mg taken orally three times daily for 5 days
Placebo Comparator: placebo	Drug: matching placebo; matching placebo taken orally three times daily for 5 days.

Outcome Measures

Primary Outcome Measures :

1. Time to Healing of Genital Lesions [ Time Frame: Days 1-5, 7, 9, 11, 13 ]
   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

Secondary Outcome Measures :

1. Time to First Negative Herpes Simplex Virus (HSV) DNA PCR [ Time Frame: Days 1-5, 7, 9, 11, 13 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

South Africa

Reproductive Health and HIV Research Unit (RHRU)

Johannesburg, South Africa

Zambia

Center for Infectious Disease Research of Zambia (CIDRZ)

Lusaka, Zambia

Sponsors and Collaborators

University of Washington

National Institute of Allergy and Infectious Diseases (NIAID)

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Connie Celum, MD, MPH; University of Washington
• Principal Investigator: Anna Wald, MD, MPH; University of Washington

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Connie Celum, MPH/ Principal Investigator, Protocol Co-Chair, University of Washington
• ClinicalTrials.gov Identifier: NCT00808405 History of Changes
• Other Study ID Numbers: 34708-A; U01AI052054 ( U.S. NIH Grant/Contract )
• First Posted: December 15, 2008
• Results First Posted: May 18, 2012
• Last Update Posted: December 11, 2013
• Last Verified: November 2013

Keywords provided by Connie Celum, University of Washington:

herpes simplex virus; acyclovir; HSV shedding; women; Africa

Additional relevant MeSH terms:

Herpes Genitalis; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Genital Diseases, Male; Genital Diseases, Female; Acyclovir; Antiviral Agents; Anti-Infective Agents