Condition category
Urological and Genital Diseases
Date applied
27/09/2005
Date assigned
03/02/2006
Last edited
26/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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 catchment’s 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

  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