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 |
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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
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 |
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hoffmani@med.unc.edu |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Acyclovir, benzathine penicillin, ciprofloxacin |
Primary outcome measure | 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 study start date | 01/09/2004 |
Completion date | 01/01/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 500 |
Key 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 |
Key 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 |
Date of first enrolment | 01/09/2004 |
Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Malawi
- United States of America
Study participating centre
Center for Infectious Diseases
Chapel Hill
27599-3368
United States of America
27599-3368
United States of America
Sponsor information
University of North Carolina (USA)
University/education
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 |
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hoffmani@med.unc.edu | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/12/2013 | Yes | No |