Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

N/ACompletedNCT02053142

University of North Carolina, Chapel Hill74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ulcers of Female Genital Organs

Interventions

AcyclovirDRUG

Single dose of acyclovir 200mg was given for pk study

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Outcomes

Primary Outcomes

Area under the Curve (AUC)

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.

Time frame: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration

Secondary Outcomes

Time to re-epithelization and time to cessation of HSV shedding

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.

Time frame: days 1-5, 7, 9, 11 and 13

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.