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Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF) (SURF)

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Lopinavir/ritonavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring pediatric, pharmacokinetics, HIV infection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subject is at least 18 and not older than 55 years of age on the day of the first dosing.
Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing.
Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
Subject is in good age appropriate health condition
Subject has a normal blood pressure and pulse rate, according to the investigator's judgment.
Female subject is either not of childbearing potential, or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or copper intrauterine device (IUD); has a vasectomized partner; or total abstinence from sexual intercourse.

Exclusion Criteria:

Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
Positive HIV test.
Positive hepatitis B or C test.
Therapy with any drug, including oral contraceptives.
Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastrointestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
History of or current abuse of drugs, alcohol or solvents.
Inability to understand the nature and extent of the trial and the procedures required.
Participation in a drug trial within 60 days prior to the first dose.
Donation of blood within 60 days prior to the first dose.
Febrile illness within 3 days before the first dose.
Pregnancy or breastfeeding.

Sites / Locations

Radboud University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Kaletra tablets

Lopimune granules

Lopimune tablets

Outcomes

Primary Outcome Measures

Plasma concentrations of lopinavir and ritonavir.

Secondary Outcome Measures

safety: adverse events

Full Information

NCT ID

NCT00665951

First Posted

April 23, 2008

Last Updated

November 9, 2020

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00665951

Brief Title

Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)

Acronym

SURF

Official Title

The Pharmacokinetics of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children: a Pilot Study of Lopimune vs. the Branded Product (SURF Study).

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation. The formal bioequivalence study with adequate power will be conducted by the manufacturer. In order to get data independently from the manufacturer and to have this information in an earlier phase, this small pilot study is initiated. The initial study showed a declined bioavailability of the granules under fasting conditions. The study has been extended with an arm determining the pharmacokinetics of the granules after food (compared to the oral solution taken with food).

Detailed Description

Cipla has developed two co-formulated forms of lopinavir/ritonavir for second-line antiretroviral therapy for children: Lopimune granules and Lopimune tablets. They contain 100mg lopinavir and 25mg ritonavir. Primary objective of this study: To determine the pharmacokinetic profile of lopinavir and ritonavir in two different co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative, healthy adult subjects, and to compare this to the branded product. Secondary objective: To evaluate the safety of single-dose administration of the two generic co-formulations of lopinavir/ritonavir and compare this to the branded product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

pediatric, pharmacokinetics, HIV infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Kaletra tablets

Arm Title

Arm Type

Experimental

Arm Description

Lopimune granules

Arm Title

Arm Type

Experimental

Arm Description

Lopimune tablets

Intervention Type

Drug

Intervention Name(s)

Lopinavir/ritonavir

Other Intervention Name(s)

Kaletra

Intervention Description

Lopinavir/ritonavir 200/50mg; 2 tablets; single dose

Intervention Type

Drug

Intervention Name(s)

Lopinavir/ritonavir

Other Intervention Name(s)

Lopimune granules

Intervention Description

Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose

Intervention Type

Drug

Intervention Name(s)

Lopinavir/ritonavir

Other Intervention Name(s)

Lopimune tablets

Intervention Description

Lopinavir/ritonavir 100/25mg; 4 tablets; single dose

Primary Outcome Measure Information:

Title

Plasma concentrations of lopinavir and ritonavir.

Time Frame

0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 24 and 32 hours post ingestion (11 samples) on Days 1, 8 and 15.

Secondary Outcome Measure Information:

Title

safety: adverse events

Time Frame

entire study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is at least 18 and not older than 55 years of age on the day of the first dosing. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. Subject is in good age appropriate health condition Subject has a normal blood pressure and pulse rate, according to the investigator's judgment. Female subject is either not of childbearing potential, or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or copper intrauterine device (IUD); has a vasectomized partner; or total abstinence from sexual intercourse. Exclusion Criteria: Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. Positive HIV test. Positive hepatitis B or C test. Therapy with any drug, including oral contraceptives. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastrointestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. History of or current abuse of drugs, alcohol or solvents. Inability to understand the nature and extent of the trial and the procedures required. Participation in a drug trial within 60 days prior to the first dose. Donation of blood within 60 days prior to the first dose. Febrile illness within 3 days before the first dose. Pregnancy or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Burger

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University Medical Centre

City

Nijmegen

State/Province

Gelderland

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

20056686

Citation

de Kanter CT, Colbers EP, Fillekes Q, Hoitsma A, Burger DM. Pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of paediatric Lopimune versus the branded product in healthy adult volunteers. J Antimicrob Chemother. 2010 Mar;65(3):538-42. doi: 10.1093/jac/dkp472. Epub 2010 Jan 7.

Results Reference

result

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Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)

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