PACTR202102566734864
Completed
Phase 1
Drug-drug interaction in the co-administration of the antiretroviral drugs and the antischistomicide praziquantel
AiBST0 sites32 target enrollmentMay 4, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV/AIDS
- Sponsor
- AiBST
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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