Lopinavir (LPV) Dose Reduction

NCT01159275 | Completed Phase 1

• 1 other identifier: HIV-NAT 085
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• AUC, Cmin, Cmax of LPV/r between Aluvia and generic

  AUC, Cmin, Cmax of LPV/r between Aluvia and generic

  week 2

Study Arms (2)

1

OTHER

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)

2

OTHER

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)

Interventions

Generic LPV/r and Aluvia (pharmacokinetics) DRUG

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

1

Aluvia and Generic LPV/r (pharmacokinetics) DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Ministry of Education, Thailand: collaborator

Study Sites (1)

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Related Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

MeSH Terms

Interventions

lopinavir-ritonavir drug combination; Pharmacokinetics

Intervention Hierarchy (Ancestors)

Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Anchalee Avihingsanon, MD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)