GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
NCT ID: NCT00808405
Last Updated: 2013-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
88 participants
INTERVENTIONAL
2009-01-31
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
acyclovir
acyclovir
400mg taken orally three times daily for 5 days
placebo
matching placebo
matching placebo taken orally three times daily for 5 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
acyclovir
400mg taken orally three times daily for 5 days
matching placebo
matching placebo taken orally three times daily for 5 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HSV-2 seropositive (Focus HerpeSelect \>3.4)
* At least one prior occurrence of GUD
* 18-50 years of age
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institutes of Health (NIH)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Connie Celum
MPH/ Principal Investigator, Protocol Co-Chair
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Connie Celum, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Anna Wald, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Reproductive Health and HIV Research Unit (RHRU)
Johannesburg, , South Africa
Center for Infectious Disease Research of Zambia (CIDRZ)
Lusaka, , Zambia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Lu 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.
Baeten 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
34708-A
Identifier Type: -
Identifier Source: org_study_id