Genital Ulcer Disease (GUD) Urological and Genital Diseases Genital Ulcer Disease (GUD)
Conditions
Interventions
A combination of acyclovir, benzathine penicillin and ciprofloxacin versus a combination of placebo, benzathine penicillin and ciprofloxacin
Sponsors
University of North Carolina (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Malawi
Outcome results
None listed