Drug-drug interaction in the co-administration of the antiretroviral drugs and the antischistomicide praziquantel

Phase 1

• Conditions: HIV/AIDS; schistosomiasis

• Registration Number: PACTR202102566734864
• Lead Sponsor: AiBST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Male
Black Zimbabwean
Age between 18 and 40 years
BMI between 18 and 30
HIV, Hepatitis B and C negative
Able to give consent
Non-smoking
Lab screening and ECG within the limits stipulated in the protocol
Healthy as determined by medical examination

Exclusion Criteria

HIV positive
any current or past history of psychiatric disorder
subjects receiving any prescription or over the counter product
use of any recreational drug
subjects who have eaten grapefruit or drunk grapefruit juice during the last 15 days before administration of study drug
subjects who had xanthine containing beverages (coffee, tea, chocolates, etc) 48 hours prior to study drug administration
history of hepatic, renal, GI, heart, lung, neurological, endocrine, chronic infections or disease
subjects suffering from any acute disease at screening or check in
Alanine S. Transaminase (AST)/ Alanine L. Transaminase (ALT) >3 times upper limit of normal (ULN)
Bilirubin >2.5 times ILN
Amylase > 2 times ULN
Absolute Neutrophil Count <1000/ml
Hgb < 9.0g/dl
Platelets > 50 000 cells/mm3
serum creatinine >2.5 mg/dl

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC, Cmax

Secondary Outcome Measures

Name	Time	Method
Tmax, half life and elimination rate constant