PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lihir Medical Centre
• Treatments: Albendazole; Azithromycin; Diethylcarbamazine; Ivermectin

Criteria

Inclusion Criteria:

• Adult aged 18-65

• Able to give informed consent

Exclusion Criteria:

• Known chronic illness

• Hb <7 at baseline

• Liver function or Creatinine * 1.5 Upper Limit of Normal

• Urinary tract infection at baseline

• Pregnancy (female participants only)

• Routine medications which interact with study drugs

• Lactose/Gluten intolerance

• Permanent disability impeding study participation