Welcome
Support Centre
23 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A randomized placebo controlled trial of a combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin for the syndromic treatment of genital ulcer disease in Malawi
ISRCTN ISRCTN32121857
DOI 10.1186/ISRCTN32121857
ClinicalTrials.gov identifier
EudraCT number
Public title A randomized placebo controlled trial of a combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin for the syndromic treatment of genital ulcer disease in Malawi
Scientific title
Acronym N/A
Serial number at source 04-MED-388
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 1990ís, 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).
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Malawi
Disease/condition/study domain Genital Ulcer Disease (GUD)
Participants - 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 catchmentís area and with intention to stay for at least one month
Participants - 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
Anticipated start date 01/09/2004
Anticipated end date 01/01/2006
Status of trial Completed
Patient information material
Target number of participants 500
Interventions A combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin
Primary outcome measure(s) 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 measure(s) 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
Sources of funding 1. National AIDS Commission
2. Malawi Ministry of Health, Lilongwe, Malawi
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24220352
Contact name Mr  Irving  Hoffman
  Address Center for Infectious Diseases

1700 MLK Jr. Boulevard

Suite 129

CB# 3368
  City/town Chapel Hill
  Zip/Postcode 27599-3368
  Country United States of America
  Tel +1 919 843 6324
  Fax +1 919 843 6195
  Email hoffmani@med.unc.edu
Sponsor University of North Carolina (USA)
  Address Center for Infectious Diseases

130 Mason Farm road

Bioinformatics building

CB# 7030
  City/town Chapel Hill
  Zip/Postcode 27599-7030
  Country United States of America
  Tel +1 919 966 2536
  Fax +1 919 966 6714
  Email hoffmani@med.unc.edu
Date applied 27/09/2005
Last edited 26/06/2014
Date ISRCTN assigned 03/02/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.