Onchocerciasis (Onchocerca volvulus) Infections and Infestations Onchocerciasis
Conditions
Interventions
The participants will be randomised and assigned to one of the following five treatment regimens:
Treatment regimen 1 (n=150):
a. 6 weeks doxycycline 200 mg (2 capsules/day)
b. 6 weeks placebo mat
Amansie Central and Adanse South Districts, Ashanti Region). The study-drugs will be distributed ad personam by the research staff and drug intake monitored on a daily basis for 6 weeks.
To assess t
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women between 18-55 years 2. Good general health without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles 3. Body weight (BW): 40-70 kg 4. Presence of at least 1 palpable onchocercoma
Exclusion criteria
Exclusion criteria: 1. Known intolerance to the study drugs (doxycycline, rifampicin) 2. Pregnancy (if not obvious, all women are tested by dipstick chemistry (ß-hCG), the test will be carried out pre-treatment and every 2 weeks during treatment) 3. Currently breast-feeding 4. History of severe allergic reaction or anaphylaxis 5. History of alcohol or drug abuse 6. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, metabolic, rheumatologic or renal disease as assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analyses 7. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-GT greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche) 8. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche) 9. Laboratory evidence of diabetes (urine dipstick chemistry) 10. Behavioural, cognitive or psychiatric disease that, in the opinion of the trial clinician, affects the ability of the participant to understand and comply with the study 11. Severe asthma (emergency room visit or hospitalisation) 12. Undergone splenectomy 13. Participation in other drug trials concurrent with this study 14. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of a participant in the trial or would render the subject unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of nodules (onchocercomata) with normal embryogenesis assessed by histology 6 and 20 months after the start of drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of worm embryogenesis (normal embryos/degenerated embryos/no embryos) assessed by histology from onchocercomata excised 6 and 20 months after the start of drug administration 2. Macrofilaricidal activity of the different treatment arms assessed by histology from onchocercomata excised 20 months after the start of drug administration 3. Reduction or absence of Wolbachia bacteria in adult worms assessed by immunohistology (using anti-Wolbachia antibodies) and polymerase chain reaction (PCR) measured 6 and 20 months after the start of drug administration 4. Microfilarial load in the skin measured pre-treatment as well as 6 and 20 months after the start of drug administration 5. Parasite specific immuno-globulin subclasses and cytokine responses/angiogenesis factors measured pre-treatment as well as 6 and 20 months after the start of drug administration For all the above mentioned primary and secondary outcome measures: Treatment regimens 2 to 4 will subsequently be tested first for superiority compared to placebo (regimen 5) and second for equivalence to the standard therapy (regimen 1). | — |
Countries
Ghana
Outcome results
None listed