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 https://doi.org/10.1186/ISRCTN32121857
Secondary identifying numbers 04-MED-388
Submission date
27/09/2005
Registration date
03/02/2006
Last edited
26/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Irving Hoffman
Scientific

Center for Infectious Diseases
1700 MLK Jr. Boulevard
Suite 129
CB# 3368
Chapel Hill
27599-3368
United States of America

Phone +1 919 843 6324
Email hoffmani@med.unc.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesControl 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 1990’s, 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedGenital Ulcer Disease (GUD)
InterventionA combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Acyclovir, benzathine penicillin, ciprofloxacin
Primary outcome measure1. 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 measures1. 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 study start date01/09/2004
Completion date01/01/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteria1. 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 catchment’s area and with intention to stay for at least one month
Key exclusion criteria1. 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
Date of first enrolment01/09/2004
Date of final enrolment01/01/2006

Locations

Countries of recruitment

  • Malawi
  • United States of America

Study participating centre

Center for Infectious Diseases
Chapel Hill
27599-3368
United States of America

Sponsor information

University of North Carolina (USA)
University/education

Center for Infectious Diseases
130 Mason Farm road
Bioinformatics building
CB# 7030
Chapel Hill
27599-7030
United States of America

Phone +1 919 966 2536
Email hoffmani@med.unc.edu
ROR logo "ROR" https://ror.org/0130frc33

Funders

Funder type

Government

National AIDS Commission

No information available

Malawi Ministry of Health, Lilongwe, Malawi

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2013 Yes No