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

November 9, 2020 updated by: Radboud University Medical Center

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).

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Radboud University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Kaletra tablets
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
Other Names:
  • Kaletra
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
Other Names:
  • Lopimune granules
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other Names:
  • Lopimune tablets
Experimental: B
Lopimune granules
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
Other Names:
  • Kaletra
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
Other Names:
  • Lopimune granules
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other Names:
  • Lopimune tablets
Experimental: C
Lopimune tablets
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
Other Names:
  • Kaletra
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
Other Names:
  • Lopimune granules
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other Names:
  • Lopimune tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Measures

Outcome Measure
Time Frame
safety: adverse events
Time Frame: entire study
entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: David M Burger, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCN-AKF 07.04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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