Lopinavir (LPV) Dose Reduction

Pharmacokinetics of Pediatric Aluvia® (Lopinavir /Ritonavir 100/25 mg) and Generic Lopinavir/Ritonavir Tablet Formulation (200/50 mg) in Clinically and Virologically Stable HIV-1 Infected Thai Adults

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01159275

Enrollment

Registered

2010-07-09

Start date

2009-07-31

Completion date

2010-03-31

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infections

Keywords

lopinavir/ritonavir, pharmacokinetics, HIV-1 infected adults, aim to investigate the lower dose of boosted lopinavir in Thais and to compare the levels of lopinavir/ritonavir from Abbot and GPO

Brief summary

The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

Detailed description

This is a prospective, 2 arms, randomized intensive PK study with cross over design. This design will provide us optimal information to answer our research question. First and most important, we can assess the PK when lopinavir/r is used in a dose reduced form. By randomizing the patients to either Abbott's pediatric Aluvia dose reduction or India generic LPV/r dose reduction will allow us to assess the differences in AE severity and frequency. Using the standard abbott product as a control our study will provide important information about the bioavailability of the generic product. Although it's not an original BE design we must be able to make preliminary comparisons.

Interventions

DRUGGeneric LPV/r and Aluvia (pharmacokinetics)

Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID

DRUGAluvia and Generic LPV/r (pharmacokinetics)

First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Signed informed consent 2. Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA) 3. Age\> 18 years 4. Have been on standard dose of any PI containing regimen for at least 4 weeks prior to study entry 5. Currently having no AIDS defining illness 6. Plasma HIV RNA \< 50 copies/mL for at least 24 weeks 7. Willing to adhere to the protocol requirements

Exclusion criteria

1. Any history of taking CYP450 inhibitors or inducers, or any gastric acid-reducing drugs within 14 days of enrollment in the study 2. Current pregnancy or lactating 3. Active opportunistic infection 4. ALT/ AST more than 2x upper limit 5. creatinine more than 1.5 time the upper limit 6. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion 7. History of sensitivity/idiosyncrasy to the drug or chemically related compounds or pharmaceutical excipients which may be employed in the study. 8. Active drug abuse

Design outcomes

Primary

Measure	Time frame	Description
AUC, Cmin, Cmax of LPV/r between Aluvia and generic	week 2	AUC, Cmin, Cmax of LPV/r between Aluvia and generic

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026