Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the safety and tolerability of moxidectin in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to determine whether it is safe enough to expose a number of subjects sufficient for obtaining statistically significant data on the safety and efficacy of moxidectin relative to ivermectin.

Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicines Development for Global Health; World Health Organization
• Collaborator: World Health Organization
• Treatments: Ivermectin; Milbemycin; Moxidectin

Criteria

Inclusion Criteria:

1. Written, signed (or thumb-printed), and dated informed consent

2. Aged 18 to 60 years, inclusive

3. Body weight ≥ 40 kg for women and ≥ 45 kg for men

4. Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment.

5. Healthy, as determined by a physician on the basis of a physical examination, ECG, and a thorough review of the medical history and clinical laboratory results

6. Adequate hematologic, renal, and hepatic function

7. Skin microfilarial density within the required range for the cohort

Exclusion Criteria:

1. Participation in any studies other than purely observational ones, within 4 weeks before test article administration.

2. Any vaccination within 4 weeks before test article administration

3. Acute infection requiring therapy within the last 10 days before test article administration

4. Administration of any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within 10 days prior to test article administration or any condition currently requiring regular medication

5. Clinically significant ECG abnormalities or history of cardiac abnormality

6. Past or current history of neurological or neuropsychiatric disease or epilepsy

7. Subjects with orthostatic hypotension at the screening evaluation

8. History of drug or alcohol abuse or regular use of ≥ 3 cigarettes per day

9. Use of alcohol or other drugs of abuse within 72 hours before test article administration

10. Any condition, in the investigator's opinion, that places the subject at undue risk

11. Subjects who have donated blood within 8 weeks before study entry

12. Subjects with ocular onchocerciasis in cohorts intended to enroll subjects with mild infection. Ocular onchocerciasis is defined by the presence of live or dead microfilariae, onchocercal punctate opacities, onchocercal lesions of the posterior segment or lesions that mimic those seen in onchocerciasis.

13. Subjects with hyperreactive onchodermatitis

14. Antifilarial therapy within the previous 5 years

15. Coincidental infection with Loa Loa

16. Female subjects of childbearing potential with a contraindication to DMPA if not on Norplant

17. Any other condition which the investigator feels would exclude the subject from the study