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

NCT00665951 | Completed Phase 1

• 1 other identifier: UMCN-AKF 07.04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Keywords

pediatric; pharmacokinetics; HIV infection

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of lopinavir and ritonavir.

  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 Outcomes (1)

• safety: adverse events

  entire study

Study Arms (3)

A

ACTIVE COMPARATOR

Kaletra tablets

Drug: Lopinavir/ritonavir

B

EXPERIMENTAL

Lopimune granules

Drug: Lopinavir/ritonavir

C

EXPERIMENTAL

Lopimune tablets

Drug: Lopinavir/ritonavir

Interventions

Lopinavir/ritonavir DRUG

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

Also known as: Kaletra

A

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 20056686 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Lopinavir; lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David M Burger

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 24, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

NL (1)