Onchocerciasis (river blindness), Loiasis Infections and Infestations
Conditions
Interventions
Current interventions as of 09/02/2024:
The study is a prospective, randomized, controlled, monocentric, open-label, parallel-group,
interventional phase II pilot trial with blinded endpoint evaluat
Sponsors
University of Buea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 09/02/2024: 1. Willingness to participate in the study by signing the Informed Con- sent Form (ICF) 2. Age: 18-55 years 3. Body weight: 50 – 90 kg 4. Presence of at least one Onchocerca nodule detected by palpation 5. OV MF-positive 6. LL MF negative (group “a”) 7. LL MF positive: < 8.000 MF (group “b” only) 8. Good general health without any clinical condition requiring medication 9. No previous history of tuberculosis 10. Negative for active TB (PCR analysis) 11. Participants with the ability to follow study instructions and are likely to attend and complete all required visits _____ Previous inclusion criteria: 1. Willingness to participate in the study by signing the Informed Consent Form (ICF) 2. 15 - 55 years 3. Bodyweight =50 kg 4. Presence of at least 2 medium-sized or one large Onchocerca nodule detected by palpation 5. MF-positive 6. Good general health without any clinical condition requiring medication 7. No previous history of tuberculosis 8. Participants with the ability to follow study instructions and are likely to attend and complete all required visits
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 09/02/2024: General Exclusion Criteria: 1. Participants not able to give consent 2. Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial 3. Participants taking any concomitant medication (i.e. medication that cannot be discontinued during the trial; Women taking hormonal contraceptives should continue to take it, but they have to agree to use additional methods of contraception). Supplements (e.g.vitamins (with the exception of vitamin D which is contraindicated)) are allowed. 4. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure (RIF or any member of the Rifamycins (e.g. Rifapentin, Rifaximin), ALB or any member of the Benzimidazole group (e.g. Mebendazole), DOX or any member of the Tetracyclines (e.g. Chlortetracyclin, Minocyclin)) 5. Treatment with the trial drugs rifampicin or doxycycline during the previous year. 6. Simultaneous participation in any clinical trial. 7. Participants with a physical or psychiatric condition which at the 8. investigator’s discretion may put the participant at risk, may confound the trial results, or may interfere with the participation in this clinical trial 9. Known or persistent abuse of medication, drugs or alcohol 10. Pregnant women 11. Breastfeeding women 12. Women of childbearing potential, who are not willing or able to use methods to prevent a pregnancy for the entire treatment duration plus additional 4 weeks after treatment end in addition to hormonal contraception (e.g. condoms) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases 13. Men with partners of childbearing potential, who are not willing or able to use methods to prevent a pregnancy (e.g. condoms) for the entire treatment duration plus additional 4 weeks after treatment end Indication specific exclusion criteria: 1. History or clinical signs of Tuberculosis (TB) or treatment against TB 2. Positive for active TB (PCR analysis) 3. History of Porphyria 4. History of photosensitivity/phototoxicity 5. History of Diabetes mellitus (in addition to dipstick test for glycosuria) 6. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic or renal disease as far as can be assessed by history of participants, physical examination, and/or laboratory examinations 7. Evidence of acute Hepatitis A and of acute or chronic Hepatitis B or C 8. Laboratory evidence of liver disease (AST, ALT, ?GT greater than the upper limit of normal, total bilirubin greater than 1.5 the upper limit of normal) 9. Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal) 10. Laboratory evidence of Leukopenia (leukocytes 8,000 MF (group “b”) _____ Previous exclusion criteria: General Exclusion Criteria: 1. Participants not able to give consent 2. Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial 3. Participants co-infected with Loa Loa 4. Participants taking any concomitant medication (i.e. medication that cannot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/02/2024: Evaluation of adult female worm embryogenesis assessed by immunohistology 18 (+3) months after treatment onset: a. normal embryos b. degenerated embryos c. no embryos. _____ Previous primary outcome measure: Absence of Wolbachia endobacteria in adult female worms assessed by immunohistology 6 months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/02/2024: 1. Absence of Wolbachia endobacteria in adult female worms assessed by immunohistology 18 (+3) months after treatment onset. 2. Reduction of Wolbachia bacteria in the nodules assessed by PCR 18 (+3) months after treatment onset. 3. Proportion of dead and alive female adult worms assessed by immunohistology at 18 (+3) months after treatment onset. 4. Reduction of OV MF in the skin at 3.5, 6, 12 and 18 (+3) months after treatment onset. 5. Absence of OV MF in the skin at 3.5, 6, 12 and 18 (+3) months after treatment onset. 6. Reduction of the Wolbachia in the skin OV MF assessed by PCR at 3.5, 6, 12 and 18 (+3) months after treatment onset. 7. Reduction of LL MF in the blood at 3.5, 6, 12 and 18 (+3) months after treatment onset (only treatment groups 1b, 3b and 5b). 8. Absence of LL MF in the blood at 3.5, 6, 12 and 18 (+3) months after treatment onset (only treatment groups 1b, 3b and 5b). 9. Lack of Serious Adverse Events (SAEs) related to the activity of the combination of RIF plus ALB or DOX alone in participants co-infected with Onchocerca volvulus and Loa loa. 10. Adverse events (AEs) as well as Serious Adverse Events (SAEs) in response to the different treatments will be assessed and described in the scope of the daily observed treatment (DOT). 11. Preparation of a pharmacokinetic profile for the combinations RIF + ALB and DOX + ALB compared to the profile of DOX or ALB alone (PK-subgroup) _____ Previous secondary outcome measures: 1. Wolbachia bacteria in adult worms assessed by PCR at baseline and 6 months after treatment onset 2. Evaluation of worm embryogenesis assessed by histology 6 months after treatment onset: 2.1. Normal embryos 2.2. Degenerated embryos 2.3. No embryos 3. Microfilariae in the skin at baseline, 3.5 and 6 months after treatment onset 4. Wolbachia in the skin MF assessed by PCR at baseline, 3.5 and 6 months after treatment onset 5. Adverse events (AEs) as well as Serious Adverse | — |
Countries
Cameroon
Contacts
Public ContactSamuel Wanji
Outcome results
None listed