Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Irving Hoffman


Contact details

Center for Infectious Diseases
1700 MLK Jr. Boulevard
Suite 129
CB# 3368
Chapel Hill
United States of America
+1 919 843 6324

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet


Genital Ulcer Disease (GUD)


A combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin

Intervention type



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


Overall trial end date


Reason abandoned


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 catchment’s area and with intention to stay for at least one month

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Center for Infectious Diseases
Chapel Hill
United States of America

Sponsor information


University of North Carolina (USA)

Sponsor details

Center for Infectious Diseases
130 Mason Farm road
Bioinformatics building
CB# 7030
Chapel Hill
United States of America
+1 919 966 2536

Sponsor type




Funder type


Funder name

National AIDS Commission

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Malawi Ministry of Health, Lilongwe, Malawi

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:

Publication citations

  1. 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.

Additional files

Editorial Notes