Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

University of North Carolina (UNC)

Status: Completed

Conditions: Ulcers of Female Genital Organs

Treatments: Drug: Acyclovir; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02053142

CIDRZ 1208/IRB12-0390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 3 patient groups, including a placebo group

Part 1 PK

Experimental group

Description:

400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.

Treatment:

Drug: Acyclovir

Acyclovir

Active Comparator group

Description:

400 mg Acyclovir three times daily for 5 days

Treatment:

Drug: Acyclovir

Placebo

Placebo Comparator group

Description:

Placebo three times daily for 5 days

Treatment:

Drug: Placebo