Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02053142
• Date of registration: 31/01/2014
• Prospective Registration: No
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
• Scientific title: 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: January 2009
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02053142
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Stewart Reid, MD
• Affiliation: Centre for Infectious Disease Research in Zambia

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Ulcers of Female Genital Organs

Intervention(s)

Drug: Placebo

Drug: Acyclovir

Primary Outcome(s)

Area under the Curve (AUC) [Time Frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration]

Secondary Outcome(s)

Time to re-epithelization and time to cessation of HSV shedding [Time Frame: days 1-5, 7, 9, 11 and 13]

Secondary ID(s)

CIDRZ 1208/IRB12-0390

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)