Bioequivalence Study of Pediatric Formulations to Treat HIV Infection

NCT01469520 | Unknown Phase 1 DMC

• 2 other identifiers: RU 2010-732010-73
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in comparison to an innovator product. Establishing the bioequivalence of a newly developed age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral dispersible tablet or a reconstitutable suspension for children is invaluable for future product registration and availability of the products to children, thus filling the void in pediatric HIV/AIDS therapy.

Conditions

HIV; AIDS

Keywords

HIV; AIDS; Treatment

Outcome Measures

Primary Outcomes (1)

• Bioequivalence between the tests and reference drugs

  The BE criterion established by the Food and Drug administration requires that the 90 % confidence interval of the ratio of suspension or tablet/co-administered liquid mixtures of the individual drugs for all the three parameters (Cmax, AUC0-t, AUC0-∞)should lie within 80 to 125 % range.

  90 days

Study Arms (3)

Reference

ACTIVE COMPARATOR

Co-administered liquid mixture of Epivir® (lamivudine) solution, Retrovir® (zidovudine)and Viramune® (nevirapine)

Drug: Epivir®, Retrovir® and Viramune®

Test product

ACTIVE COMPARATOR

Fixed dose combination of lamivudine, zidovudine and nevirapine reconstitutable suspension

Drug: Lamivudine, Zidovudine and nevirapine; Drug: Lamivudine, zidovudine, nevirapine

Test Product

ACTIVE COMPARATOR

Fixed dose combination combination (Lamivudine, Zidovudine and Nevirapine)tablet

Drug: Lamivudine, Zidovudine and nevirapine; Drug: Lamivudine, zidovudine, nevirapine

Interventions

Epivir®, Retrovir® and Viramune® DRUG

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

Also known as: Lamivudine, Zidovudine, Nevirapine

Reference

Lamivudine, Zidovudine and nevirapine DRUG

20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension

Also known as: Lamivudine, Zidovudine, Nevirapine

Test Product; Test product

Lamivudine, zidovudine, nevirapine DRUG

Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.

Also known as: Lamivudine, Zidovudine, Nevirapine

Test Product; Test product

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The eligibility criteria included adults between 22 and 55 years;
• 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.

You may not qualify if:

• Abnormal laboratory biochemistry values;
• 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.

Sponsors & Collaborators

• Elim Pediatric Pharmaceuticals Inc.: lead

Study Sites (1)

Bowen University Teaching Hospital

Ogbomoso, Oyo State, 234, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 17503667 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Lamivudine; Zidovudine; Nevirapine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine; Pyridines

Study Officials

• Moji C Adeyeye, Ph.D

  Elim Pediatric Pharmaceuticals Inc. and Roosevelt University

  PRINCIPAL INVESTIGATOR

• Daniel A Gbadero, MD

  Bowen University Teaching Hospital, Ogbomoso, Nigeria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 10, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

NG (1)