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

NCT00808405 | Completed Results

• 2 other identifiers: 34708-AU01AI052054
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Herpes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to First Negative Herpes Simplex Virus (HSV) DNA PCR

  Days 1-5, 7, 9, 11, 13

Study Arms (2)

acyclovir

ACTIVE COMPARATOR

Drug: acyclovir

placebo

PLACEBO COMPARATOR

Drug: matching placebo

Interventions

acyclovir DRUG

400mg taken orally three times daily for 5 days

acyclovir

matching placebo DRUG

matching placebo taken orally three times daily for 5 days.

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV negative as determined by concordant rapid testing
• HSV-2 seropositive (Focus HerpeSelect \>3.4)
• At least one prior occurrence of GUD
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Reproductive Health and HIV Research Unit (RHRU)

Johannesburg, South Africa

Location

Center for Infectious Disease Research of Zambia (CIDRZ)

Lusaka, Zambia

Location

Related Publications (3)

• 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.

  PMID: 18572080 BACKGROUND

• 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.

  PMID: 22330926 BACKGROUND

• 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.

  PMID: 22183840 DERIVED

MeSH Terms

Conditions

Herpes Genitalis; Herpes Simplex

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Connie Celum, MD, MPH
• Organization: University of Washington

ccelum@uw.edu

206-520-3824

Study Officials

• Connie Celum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Anna Wald, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MPH/ Principal Investigator, Protocol Co-Chair

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: December 15, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: December 11, 2013
• Results First Posted: May 18, 2012

Record last verified: 2013-11

Locations

ZA (1)