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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
PACTR202102566734864 |
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Date of registration:
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04/05/2020 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Drug-drug interaction in the co-administration of the antiretroviral drugs and the antischistomicide praziquantel
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Scientific title:
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Drug-drug interaction in the co-administration of the antiretroviral drugs and the antischistomicide praziquantel |
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Date of first enrolment:
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13/05/2019 |
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Target sample size:
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32 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=11011 |
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Study type:
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Interventional |
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Study design:
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Crossover: all participants receive all interventions in different sequence during study,Non-randomised,Numbered containers
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Phase:
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Phase-1
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Collen
Masimirembwa |
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Address:
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Wilkins Hospital Block C Cnr Josiah Tongagara/ Princess Road
0000
Harare
Zimbabwe |
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Telephone:
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+263772422951 |
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Email:
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collenmasimirembwa@yahoo.com |
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Affiliation:
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Chief Scientific Officer AiBST |
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Name:
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Georginah
Nyabadza |
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Address:
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Wilkins Hospital Block C Cnr Josiah Tongogara / Princess Road
0000
Harare
Zimbabwe |
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Telephone:
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+263773069254 |
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Email:
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georginah.nyabadza@aibst.com |
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Affiliation:
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Clinical Trial Manager |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Year(s)
Age maximum:
44 Year(s)
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
schistosomiasis
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HIV/AIDS
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schistosomiasis
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Intervention(s)
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Efavirena
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Praziquantel
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Ritonavir
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Primary Outcome(s)
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AUC, Cmax
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Secondary Outcome(s)
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Tmax, half life and elimination rate constant
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Source(s) of Monetary Support
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European and Developing Countries Clinical Trials Partnership
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Forgety Global Health and Equities Program
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Global Health Protection Program
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The World Academy of Sciences
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Ethics review
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Status: Approved
Approval date: 31/08/2018
Contact:
mrcz@mrcz.org.zw
mrcz@mrcz.org.zw
+2638644073772
mrcz@mrcz.org.zw
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