An interventional study of acyclovir and matching placebo in Genital Herpes, sponsored by University of Washington. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-11.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 88 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: acyclovir
Drug: matching placebo
400mg taken orally three times daily for 5 days
matching placebo taken orally three times daily for 5 days.
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
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
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.
| Milestone | Acyclovir | Placebo |
|---|---|---|
| Started | 61 | 27 |
| Completed | 61 | 27 |
| Not completed | 0 | 0 |
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
| Days | Acyclovir | Placebo |
|---|---|---|
| Time to Healing of Genital Lesions | 5.1 ± 0.3 | 6.0 ± 0.6 |
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
| Days | Acyclovir | Placebo |
|---|---|---|
| Time to First Negative Herpes Simplex Virus (HSV) DNA PCR | 3.0 ± 0.3 | 5.0 ± 0.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acyclovir | — | 0/61 (0%) | 0/61 (0%) |
| Placebo | — | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | Acyclovir | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 61 | 27 | 88 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Acyclovir | Placebo | Total |
|---|---|---|---|
| Mean | 38.66 ± 10.28 | 38.15 ± 10.31 | 38.5 ± 10.23 |
| Sex: Female, Male(Participants) | Acyclovir | Placebo | Total |
|---|---|---|---|
| Female | 61 | 27 | 88 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Acyclovir | Placebo | Total |
|---|---|---|---|
| Zambia | 31 | 13 | 44 |
| South Africa | 30 | 14 | 44 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Washington