Genital Herpes
Conditions
Keywords
herpes simplex virus, acyclovir, HSV shedding, women, Africa
Brief summary
To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.
Interventions
DRUGacyclovir
400mg taken orally three times daily for 5 days
DRUGmatching placebo
matching placebo taken orally three times daily for 5 days.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV negative as determined by concordant rapid testing * HSV-2 seropositive (Focus HerpeSelect \>3.4) * At least one prior occurrence of GUD * 18-50 years of age
Exclusion criteria
* Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir * Prior hypersensitivity &/or allergic reaction to acyclovir * Use of probenicid * Current use, or use within past 28 days, of an investigational agent * Currently pregnant or nursing * Currently plan to become pregnant during next 3 months * Any condition that will interfere with successful completion of study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Healing of Genital Lesions | Days 1-5, 7, 9, 11, 13 | To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | Days 1-5, 7, 9, 11, 13 | To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo |
Countries
South Africa, Zambia
Participant flow
Recruitment details
Between January and December 2009, women from Johannesburg, South Africa and Lusaka, Zambia who had previously participated in the HPTN 039 (NCT00076232) study, as well as other women in the community who presented to the research clinics with genetic ulcer disease (GUD) during the recruitment period, were invited to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| Acyclovir Acyclovir 400 mg orally three times daily | 61 |
| Placebo Matching placebo tablet | 27 |
| Total | 88 |
Baseline characteristics
| Characteristic | Acyclovir | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 27 Participants | 88 Participants |
| Age Continuous | 38.66 years STANDARD_DEVIATION 10.28 | 38.15 years STANDARD_DEVIATION 10.31 | 38.5 years STANDARD_DEVIATION 10.23 |
| Region of Enrollment South Africa | 30 participants | 14 participants | 44 participants |
| Region of Enrollment Zambia | 31 participants | 13 participants | 44 participants |
| Sex: Female, Male Female | 61 Participants | 27 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 27 |
| serious Total, serious adverse events | 0 / 61 | 0 / 27 |
Outcome results
Primary
Time to Healing of Genital Lesions
To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo
Time frame: Days 1-5, 7, 9, 11, 13
Population: Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acyclovir | Time to Healing of Genital Lesions | 5.1 Days | Standard Error 0.3 |
| Placebo | Time to Healing of Genital Lesions | 6.0 Days | Standard Error 0.6 |
Secondary
Time to First Negative Herpes Simplex Virus (HSV) DNA PCR
To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo
Time frame: Days 1-5, 7, 9, 11, 13
Population: Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acyclovir | Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | 3.0 Days | Standard Error 0.3 |
| Placebo | Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | 5.0 Days | Standard Error 0.8 |