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Trial record 6 of 8 for:    NIAID | herpes genitalis

Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02053142
First Posted: February 3, 2014
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  Purpose
This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.

Condition Intervention
Ulcers of Female Genital Organs Drug: Acyclovir Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Area under the Curve (AUC) [ Time Frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration ]
    Blood will be drawn for pharmacokinetic measures to determine whether there is a difference in African women vs. the existing AUC data for women and men in North America and Europe.


Secondary Outcome Measures:
  • Time to re-epithelization and time to cessation of HSV shedding [ Time Frame: days 1-5, 7, 9, 11 and 13 ]
    Daily assessment of response of genital lesions over 13 days by time to healing and duration of HSV shedding during acyclovir 400mg orally three times daily versus placebo three times daily for 5 days.


Enrollment: 74
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 PK
400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
Drug: Acyclovir
Single dose of acyclovir 200mg was given for pk study
Active Comparator: Acyclovir
400 mg Acyclovir three times daily for 5 days
Drug: Acyclovir
Single dose of acyclovir 200mg was given for pk study
Placebo Comparator: Placebo
Placebo three times daily for 5 days
Drug: Placebo

Detailed Description:
This is a two-part study designed to measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative. The study will also examine the time to healing of genital lesion and duration of HSV shedding from GUD among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV negative as determined by concordant rapid testing
  • HSV-2 seropositive (Focus HerpeSelect EIA >3.4)
  • At least one prior occurrence of GUD
  • 18 to 50 years of age

Exclusion Criteria:

  • Current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir
  • Prior hypersensitivity and/or allergic reaction to acyclovir
  • Use of probenecid, which prolongs renal excretion of acyclovir
  • Current use, or use within the past 28 days, of an investigational agent
  • Currently pregnant or nursing
  • Currently plan to become pregnant during the next 3 months
  • Currently consume, on average, more than 7 drinks of alcohol per week (for Part I)
  • Current use of more than 20 cigarettes daily (for Part I)
  • Any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053142


Locations
Zambia
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Stewart Reid, MD Centre for Infectious Disease Research in Zambia
  More Information

Additional Information:
Publications:
Celum, C., et al., HSV-2 Suppressive Therapy for Prevention of HIV Acquisition: Results of HPTN 039. The Lancet, in press.
Blum, M., et al., The bioavailability and pharmacokinetics of ZOVIRAX 200 mg capsules vs solution in normal volunteers at risk of developing herpes simplex virus infections (Protocol P12-83). Burroughs Wellcome Document No. TEIN/82/0001.
De Miranda, P. and D. Page, Systemic absorption and pharmacokinetics of acyclovir (ZOVIRAX) when administered orally in multiple doses of 600 mg to immunocompromised patients with herpes infections (Protocol 12-30, Dr. R. Whitley). Burroughs Wellcome Document No. TEIN/82/0007.
De Miranda, P. and D. Page, Systemic absorption and pharmacokinetics of acyclovir (ZOVIRAX) when administered orally in multiple doses of 800 mg to immunocompromised patients with herpes infections (Protocol 12-30, Dr. R. Whitley) Burroughs Wellcome Document No. TEIN/83/0001.
Blum, M. and S. Liao, Pharmacokinetics and relative bioavailability of acyclovir capsules (ZOVIRAX) after multiple oral doses (Interim summary of study P12-32) amendment). Burroughs Wellcome Document No. TYBH/83/0001.
Belec, L., et al. Impact of HSV-2 Episodic Therapy on HIV-1 and HSV-2 Genital Shedding and Ulcer Healing Among Women in Ghana and the Central African Republic: Randomized Double-Blind Placebo-Controlled trial. in XXth Annual Conference of the International Union Against STI. 2006. Versailles, France.
Paz-Bailey, G., et al. Impact of Episodic Acyclovir Therapy on Genital Ulcer Duration and HIV Shedding from Herpetic Ulcers Among Men in South Africa. in 17th International Society for STD Research Meeting. 2007. Seattle, Washington, USA.

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02053142     History of Changes
Other Study ID Numbers: CIDRZ 1208/IRB12-0390
First Submitted: January 31, 2014
First Posted: February 3, 2014
Last Update Posted: September 15, 2017
Last Verified: December 2014

Keywords provided by University of North Carolina, Chapel Hill:
Pharmacokinetics
Herpes simplex virus
Genital herpes ulcers

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Ulcer
Pathologic Processes
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