Contact information
Type
Scientific
Primary contact
Mr Irving Hoffman
ORCID ID
Contact details
Center for Infectious Diseases
1700 MLK Jr. Boulevard
Suite 129
CB# 3368
Chapel Hill
27599-3368
United States of America
+1 919 843 6324
hoffmani@med.unc.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04-MED-388
Study information
Scientific title
Acronym
Study hypothesis
Control of Sexually Transmitted Infections (STI), including Genital Ulcer Disease (GUD), has been established as an important strategy for the prevention of Human Immunodeficiency Virus (HIV) transmission. Studies have shown that GUD causes an increase in the concentration of HIV-RNA (RiboNucleic Acid) in ulcer lesions and semen, which may increase HIV transmissibility, and which is reversible with GUD treatment.
As recommended by the World Health Organization for resource poor countries, a syndromic approach to managing patients with genital ulcers is utilized in Malawi. Based on data from the early 1990s, the current syndromic management of GUD is designed to treat syphilis and chancroid only. More recent data from Lilongwe Central Hospital in Malawi, however, shows that as many as 35% of patients presenting to the Sexually Transmitted Disease (STD) clinic with GUD are infected with genital herpes. HIV seroprevalence rates are well over 50% among these genital ulcer patients. Although there is no cure for genital herpes, treatment with anti-herpetic agents can have a significant effect on its management. In addition, recent changes in the availability and price of selected anti-herpetic agents make it an affordable option for many countries as a component in the treatment of genital ulcers.
Through a randomized double blinded, placebo controlled trial, this investigation will determine if adding the anti-herpetic agent, acyclovir, to the current syndromic management of GUD improves the cure rate of genital ulcers. In addition, it will determine whether treatment with acyclovir will affect the levels of HIV-RNA in the genital secretions and blood of men and women co-infected with HIV and Herpes Simplex Virus (HSV).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Genital Ulcer Disease (GUD)
Intervention
A combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin
Intervention type
Drug
Phase
Not Specified
Drug names
Acyclovir, benzathine penicillin, ciprofloxacin
Primary outcome measures
1. To determine if the addition of acyclovir for the treatment of genital herpes will improve the cure rate of the current syndromic management for GUD in Malawi
2. To determine if HIV status affects this cure rate
Secondary outcome measures
1. To determine if GUD management, with and without treatment for genital herpes, affects the level of HIV-RNA in the blood, ulcer lesion as well as genital secretions of HIV-infected patients with GUD and whether this is related to cure rate
2. To assess the incremental cost benefit for the addition of acyclovir to the current syndromic treatment of GUD
Overall trial start date
01/09/2004
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 years or older
2. Clinically confirmed genital ulcer(s)
3. Ability to provide informed consent for participation, examination and sample collection
4. Willingness to be counselled
5. Tested and received results for HIV and other STIs
6. Resident in Lilongwe catchments area and with intention to stay for at least one month
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Younger than 18 years old
2. Known allergy to penicillin, erythromycin, acyclovir, or ciprofloxacin
3. Patients with known or evidence of renal impairment
4. Very sick requiring admission
5. Women currently menstruating
6. Pregnant or lactating mothers
Recruitment start date
01/09/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
Malawi
Trial participating centre
Center for Infectious Diseases
Chapel Hill
27599-3368
United States of America
Sponsor information
Organisation
University of North Carolina (USA)
Sponsor details
Center for Infectious Diseases
130 Mason Farm road
Bioinformatics building
CB# 7030
Chapel Hill
27599-7030
United States of America
+1 919 966 2536
hoffmani@med.unc.edu
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National AIDS Commission
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Malawi Ministry of Health, Lilongwe, Malawi
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24220352
Publication citations
-
Results
Phiri S, Zadrozny S, Weiss HA, Martinson F, Nyirenda N, Chen CY, Miller WC, Cohen MS, Mayaud P, Hoffman IF, Etiology of genital ulcer disease and association with HIV infection in Malawi., Sex Transm Dis, 2013, 40, 12, 923-928, doi: 10.1097/OLQ.0000000000000051.