Status:
COMPLETED
Lopinavir (LPV) Dose Reduction
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Ministry of Education, Thailand
Conditions:
HIV-1 Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01159275
Start Date
July 1 2009
End Date
March 1 2010
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand, 10330