Genital HerpesPK/GUDNCT00808405
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
A study testing acyclovir in people with Genital Herpes, run by University of Washington at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genital Herpes
- What is being tested?
- acyclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Reproductive Health and HIV Research Unit (RHRU)
Johannesburg
About this study
Official title: Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
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.
- Conditions
- Genital Herpes
- Being tested
- acyclovir, matching placebo
- Keywords
- herpes simplex virus, acyclovir, HSV shedding, women, Africa
- Medical subject headings
- Herpes Genitalis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acyclovirDrug
400mg taken orally three times daily for 5 days
matching placeboDrug
matching placebo taken orally three times daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| acyclovir | Active comparator | Not described Receives: Drug: acyclovir |
| placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 1-5, 7, 9, 11, 13
Secondary outcomes (1)
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
Measured: Days 1-5, 7, 9, 11, 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genital HerpesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Connie Celum, University of Washington
- Investigators
- Connie Celum, MD, MPH, Principal investigator, University of WashingtonAnna Wald, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808405
- Sponsor's protocol ID
- 34708-A
- Other IDs
- U01AI052054
- Acronym
- PK/GUD
- Status last verified
- Nov 2013
- First submitted
- 25 Nov 2008
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L; HPTN 039 Protocol Team. Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 21;371(9630):2109-19. doi: 10.1016/S0140-6736(08)60920-4.
PubMed 18572080Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW. Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations. Antimicrob Agents Chemother. 2012 May;56(5):2777-9. doi: 10.1128/AAC.06160-11. Epub 2012 Feb 13.
PubMed 22330926Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey L, Wald A, Celum C. Clinical and virologic response to episodic acyclovir for genital ulcers among HIV-1 seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-controlled trial. Sex Transm Dis. 2012 Jan;39(1):21-4. doi: 10.1097/OLQ.0b013e31823b50c6.
PubMed 22183840
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
- ClinicalTrials.gov ID
- NCT00808405
- Acronym / sponsor ID
- PK/GUD / 34708-A
- Conditions
- Genital Herpes
- Keywords
- herpes simplex virus, acyclovir, HSV shedding, women, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Dec 2008 (estimated)
- Results
- Posted 18 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acyclovir | Active comparator | Drug: acyclovir |
| placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acyclovir400mg taken orally three times daily for 5 days | Drug | acyclovir |
| matching placebomatching placebo taken orally three times daily for 5 days. | Drug | placebo |
Primary outcome
Time to Healing of Genital Lesions
Time frame: 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
1 secondary outcome
Time to First Negative Herpes Simplex Virus (HSV) DNA PCR
Time frame: Days 1-5, 7, 9, 11, 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18572080Celum C, Wald A, Hughes J, Sanchez J, Reid S, Delany-Moretlwe S, Cowan F, Casapia M, Ortiz A, Fuchs J, Buchbinder S, Koblin B, Zwerski S, Rose S, Wang J, Corey L; HPTN 039 Protocol Team. Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jun 21;371(9630):2109-19. doi: 10.1016/S0140-6736(08)60920-4.
- Background: PubMed 22330926Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW. Acyclovir achieves a lower concentration in African HIV-seronegative, herpes simplex virus 2-seropositive women than in non-African populations. Antimicrob Agents Chemother. 2012 May;56(5):2777-9. doi: 10.1128/AAC.06160-11. Epub 2012 Feb 13.
- Derived from this study: PubMed 22183840Baeten JM, Reid SE, Delany-Moretlwe S, Hughes JP, Wang RS, Wilcox E, Limbada M, Akpomiemie G, Corey L, Wald A, Celum C. Clinical and virologic response to episodic acyclovir for genital ulcers among HIV-1 seronegative, herpes simplex virus type 2 seropositive African women: a randomized, placebo-controlled trial. Sex Transm Dis. 2012 Jan;39(1):21-4. doi: 10.1097/OLQ.0b013e31823b50c6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Celum, MD, MPH principal investigator
University of Washington
Anna Wald, MD, MPH principal investigator
University of Washington
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acyclovir in people with Genital Herpes, run by University of Washington at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Healing of Genital Lesions (time frame: Days 1-5, 7, 9, 11, 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00808405, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013; AzTrials last refreshed its copy on 26 Oct 2026.