Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102566734864 Date of Approval: 03/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Drug-drug interaction in the co-administration of the antiretroviral drugs and the antischistomicide praziquantel
Official scientific title Drug-drug interaction in the co-administration of the antiretroviral drugs and the antischistomicide praziquantel
Brief summary describing the background and objectives of the trial Schistosomiasis shares the same epidemiological space with the HIV and AIDS epidemic in Sub-Saharan Africa. This presents a highly likely scenario that some children and adults who will be treated for schistosomiasis with praziquantel (PZQ) will also be on lifelong treatment with antiretroviral drugs. The purpose of the study is to conduct two drug-drug interaction studies with the following objectives: 1. To evaluate the effects of efavirenz on the pharmacokinetics of PZQ in healthy volunteers and 2. To evaluate the effect of Ritonavir on the pharmacokinetics of PZQ in healthy volunteers. The combined studies will address the question of whether these antiretrovirals can effect the efficacy and safety of PZQ in the treatment of schistosomiasis. if they do, could the dose adjustment be possible to achieve desired safety and efficacy margins.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PZQ DDI study
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,schistosomiasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 13/05/2019
Actual trial start date 22/05/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 28
Recruitment status Completed
Publication URL not yet available
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Praziquantel 40 mg/kg single dose 1 days 600 mg scored Biltricide tablets (Merck-Bayer, Germany) 28 Active-Treatment of Control Group
Experimental Group Efavirena 400mg once daily 14 days Efavirenz (Strides, India) 15
Experimental Group Ritonavir 100mg once daily 14 days 100 mg Norvir (Abbvie, SA) 13
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/08/2018 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara/ Mazoe Street Harare 0000 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome AUC, Cmax 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hours
Secondary Outcome Tmax, half life and elimination rate constant 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AiBST CCH Clinical Trial Unit 12096 Batanai Street Chitungwiza 0000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Forgety Global Health and Equities Program Stanford University School of Medicine, 300 Pasteur Drive, Grant Building S-101 Palo Alto 94304 United States of America
Global Health Protection Program Kurt-Georg-Kiesinger-Allee 3 Bonn Germany
The World Academy of Sciences Campus, Strada Costiera 11 Trieste 34151 Italy
European and Developing Countries Clinical Trials Partnership Anna van Saksenlaan 51 Den Haag 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AiBST Wikins Hospital Block C Cnr Josiah Tongogara/ Princess Road Harare 0000 Zimbabwe Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roslyn Stella Thelingwani roslyn.thelingwani@aibst.com +263773817401 Wilkins Hospital Block C Cnr J.Tongogara/Princess Road
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Senior Scientist AiBST
Role Name Email Phone Street address
Public Enquiries Georginah Nyabadza georginah.nyabadza@aibst.com +263773069254 Wilkins Hospital Block C Cnr Josiah Tongogara / Princess Road
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Clinical Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Collen Masimirembwa collenmasimirembwa@yahoo.com +263772422951 Wilkins Hospital Block C Cnr Josiah Tongagara/ Princess Road
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Chief Scientific Officer AiBST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results reported after deidentification will be shared with other investigators. Clinical Study Report IPD and other additional documents such as the clinical study report will be available indefinitely soon after publication Investigators whose proposed use of the data has been approved by an independent review committee may access the data using this link. (link not yet available). This will be available indefinitely.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available for sharing No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information