Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02053142 |
Date of registration:
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31/01/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
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Scientific title:
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Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women |
Date of first enrolment:
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January 2009 |
Target sample size:
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74 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02053142 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Stewart Reid, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Centre for Infectious Disease Research in Zambia |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ulcers of Female Genital Organs
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Intervention(s)
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Drug: Placebo
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Drug: Acyclovir
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Primary Outcome(s)
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Area under the Curve (AUC)
[Time Frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration]
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Secondary Outcome(s)
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Time to re-epithelization and time to cessation of HSV shedding
[Time Frame: days 1-5, 7, 9, 11 and 13]
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Secondary ID(s)
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CIDRZ 1208/IRB12-0390
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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