Lopinavir (LPV) Dose Reduction
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
Ministry of Education, Thailand
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01159275
First received: June 4, 2010
Last updated: July 8, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infections |
Drug: Generic LPV/r and Aluvia (pharmacokinetics) Drug: Aluvia and Generic LPV/r (pharmacokinetics) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- AUC, Cmin, Cmax of LPV/r between Aluvia and generic [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]AUC, Cmin, Cmax of LPV/r between Aluvia and generic
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
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)
Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID
|
|
2
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)
First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01159275
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159275
Locations
| Thailand | |
| HIV-NAT, Thai Red Cross AIDS Research Centre | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Ministry of Education, Thailand
Investigators
| Principal Investigator: | Anchalee Avihingsanon, MD | The HIV Netherlands Australia Thailand Research Collaboration |
More Information
Additional Information:
| Responsible Party: | Anchalee Avihingsanon, HIV-NAT |
| ClinicalTrials.gov Identifier: | NCT01159275 History of Changes |
| Other Study ID Numbers: | HIV-NAT 085 |
| Study First Received: | June 4, 2010 |
| Last Updated: | July 8, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
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 |
Additional relevant MeSH terms:
|
Ritonavir Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016