Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
NCT ID: NCT01469520
Last Updated: 2011-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2010-10-31
2011-12-31
Brief Summary
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Detailed Description
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In anticipation of such reactions,10% more of the 26 subjects will be added to the group. This will make a total of 29 volunteers during the study. Advertisements announcing the study will be posted at the Bowen University Teaching Hospital two months before the commencement of the study to invite volunteers.
Informed Consent Procedure: The volunteers will be screened using a questionnaire (see attached). The language of communication will be English or a local language used by the community. Researchers will explain to the volunteers on an individual basis, the nature of the study, what would be expected of them and their rights. Volunteers may choose to drop out of the study at any time without any restrictions. Volunteers will be informed that the screening procedure also includes physical examination and laboratory test. Following informed consent, using Consent to Participate Form (see attached) and counseling, volunteers may be enrolled for the study.
A baseline laboratory tests for: packed cell volume, white blood cell count with differentiation, platelet estimation, liver function (aspartate aminotransferase \[SGOT\], alanine aminotransferase \[SGPT\]), renal function (serum creatinine), blood urea nitrogen (BUN), pregnancy test (females only), HIV/AIDS, and hepatitis B and C tests will be done two weeks prior to dosing. Volunteers may not consume alcohol, tobacco, caffeine containing products, herbal or other drugs during the study.
Eligibility: The inclusion criteria are as follows: Adult males and females found normal on the basis of a pre-trial physical examination, medical history and the results of blood biochemistry and hematology tests; subject is competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study; willingness to be hospitalized for a 24-hour intensive sampling period.
Exclusion criteria:
* Hypersensitivity to study drugs, alcoholism, anemia, evidence of pregnancy
* Abnormal laboratory test; smokers;
* Any clinically significant diseases or findings during the screening medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
* Treatment with experimental or prescribed drugs within 30 days prior to the beginning of the study
Confidentiality: Volunteer's name as it appears on the questionnaire will be linked to an identification number. All other documents will have only the identification number instead of your name. The name will not be used in any public document. All written materials and consent forms will be stored in a locked file in the researcher's office. All materials will be destroyed by shredding five years after the completion of the research.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Reference
Co-administered liquid mixture of Epivir® (lamivudine) solution, Retrovir® (zidovudine)and Viramune® (nevirapine)
Epivir®, Retrovir® and Viramune®
12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL
Test product
Fixed dose combination of lamivudine, zidovudine and nevirapine reconstitutable suspension
Lamivudine, Zidovudine and nevirapine
20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
Lamivudine, zidovudine, nevirapine
Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
Test Product
Fixed dose combination combination (Lamivudine, Zidovudine and Nevirapine)tablet
Lamivudine, Zidovudine and nevirapine
20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
Lamivudine, zidovudine, nevirapine
Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
Interventions
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Epivir®, Retrovir® and Viramune®
12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL
Lamivudine, Zidovudine and nevirapine
20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
Lamivudine, zidovudine, nevirapine
Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy as determined on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and hematology tests;
* Subject was competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study;
* Willing to be hospitalized for the 24-hour intensive sampling period.
Exclusion Criteria
* Smokers;
* Any clinically significant diseases or findings during the screening, medical history or physical examination that, in the opinion of the investigator, may interfere with the study;
* Treatment with experimental drugs within 30 days prior to study entry.
22 Years
55 Years
ALL
Yes
Sponsors
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Elim Pediatric Pharmaceuticals Inc.
OTHER
Responsible Party
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Principal Investigators
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Moji C Adeyeye, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Elim Pediatric Pharmaceuticals Inc. and Roosevelt University
Daniel A Gbadero, MD
Role: STUDY_DIRECTOR
Bowen University Teaching Hospital, Ogbomoso, Nigeria
Locations
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Bowen University Teaching Hospital
Ogbomoso, Oyo State, Nigeria
Countries
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References
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Ellis JC, L'homme RF, Ewings FM, Mulenga V, Bell F, Chileshe R, Molyneux E, Abernethy J, van Oosterhout JJ, Chintu C, Walker AS, Gibb DM, Burger DM. Nevirapine concentrations in HIV-infected children treated with divided fixed-dose combination antiretroviral tablets in Malawi and Zambia. Antivir Ther. 2007;12(2):253-60.
Other Identifiers
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2010-73
Identifier Type: OTHER
Identifier Source: secondary_id
RU 2010-73
Identifier Type: -
Identifier Source: org_study_id