Lopinavir (LPV) Dose Reduction
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ClinicalTrials.gov Identifier: NCT01159275 |
Recruitment Status
:
Completed
First Posted
: July 9, 2010
Last Update Posted
: July 9, 2010
|
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- AUC, Cmin, Cmax of LPV/r between Aluvia and generic [ Time Frame: week 2 ]AUC, Cmin, Cmax of LPV/r between Aluvia and generic

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159275
Thailand | |
HIV-NAT, Thai Red Cross AIDS Research Centre | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Anchalee Avihingsanon, MD | The HIV Netherlands Australia Thailand Research Collaboration |
Additional Information:
Responsible Party: | Anchalee Avihingsanon, HIV-NAT |
ClinicalTrials.gov Identifier: | NCT01159275 History of Changes |
Other Study ID Numbers: |
HIV-NAT 085 |
First Posted: | July 9, 2010 Key Record Dates |
Last Update Posted: | July 9, 2010 |
Last Verified: | July 2010 |
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 |