GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women (PK/GUD)
This study has been completed.
Sponsor:
University of Washington
Collaborators:
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT00808405
First received: November 25, 2008
Last updated: May 21, 2012
Last verified: May 2012
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Purpose
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 | Intervention |
|---|---|
|
Genital Herpes |
Drug: acyclovir Drug: matching placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Time to Healing of Genital Lesions [ Time Frame: Days 1-5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]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:
- Time to First Negative Herpes Simplex Virus (HSV) DNA PCR [ Time Frame: Days 1-5, 7, 9, 11, 13 ] [ Designated as safety issue: No ]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
| Enrollment: | 88 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808405
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
Investigators
| Principal Investigator: | Connie Celum, MD, MPH | University of Washington |
| Principal Investigator: | Anna Wald, MD, MPH | University of Washington |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Connie Celum, MPH/ Principal Investigator, Protocol Co-Chair, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00808405 History of Changes |
| Other Study ID Numbers: | UO1 AI52054, UO1 AI52054 |
| Study First Received: | November 25, 2008 |
| Results First Received: | April 20, 2012 |
| Last Updated: | May 21, 2012 |
| Health Authority: | South Africa: Human Research Ethics Committee United States: Institutional Review Board Zambia: Research Ethics Committee |
Keywords provided by 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013