Pharmacokinetic Study of Two Generic co-Formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/ritonavir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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). |
- 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. ] [ Designated as safety issue: No ]
- safety: adverse events [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | September 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Kaletra tablets
|
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
Other Name: Kaletra
|
|
Experimental: B
Lopimune granules
|
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
Other Name: Lopimune granules
|
|
Experimental: C
Lopimune tablets
|
Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other Name: Lopimune tablets
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. D.M. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00665951 History of Changes |
| Other Study ID Numbers: | UMCN-AKF 07.04 |
| Study First Received: | April 23, 2008 |
| Last Updated: | February 24, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
pediatric pharmacokinetics HIV infection |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013