Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT02053142

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Ulcers of Female Genital Organs	Drug: Acyclovir Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Area under the Curve (AUC) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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.