Lopinavir (LPV) Dose Reduction

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
HIV-1 Infections

Intervention / Treatment
-----------------
* Drug: Generic LPV/r and Aluvia (pharmacokinetics)
* Drug: Aluvia and Generic LPV/r (pharmacokinetics)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA) Age> 18 years Have been on standard dose of any PI containing regimen for at least 4 weeks prior to study entry Currently having no AIDS defining illness Plasma HIV RNA < 50 copies/mL for at least 24 weeks Willing to adhere to the protocol requirements Exclusion Criteria: Any history of taking CYP450 inhibitors or inducers, or any gastric acid-reducing drugs within 14 days of enrollment in the study Current pregnancy or lactating Active opportunistic infection ALT/ AST more than 2x upper limit creatinine more than 1.5 time the upper limit Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion History of sensitivity/idiosyncrasy to the drug or chemically related compounds or pharmaceutical excipients which may be employed in the study. Active drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>First Generic LPV/r 200/50 mg BID, then cross over to Pediatric Aluvia 200/50 mg BID | Drug: Generic LPV/r and Aluvia (pharmacokinetics)<br>* Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID<br>|
| Other: 2<br>First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID | Drug: Aluvia and Generic LPV/r (pharmacokinetics)<br>* First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Cmin, Cmax of LPV/r between Aluvia and generic | AUC, Cmin, Cmax of LPV/r between Aluvia and generic | week 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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