Status:
COMPLETED
TDM of Generic Lopinavir/Ritonavir 200/50 mg
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
The Government Pharmaceutical Organization
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluating the bioavailibility safety and efficacy of the generic LPV/RTV 200/50 mg tablet formulation in a 400/100 mg BID dose in Thai HIV infected individuals.
Detailed Description
The original solid oral formulation of lopinavir/ritonavir was a soft gel capsule (SGC) in a 133/33 mg formulation. This formulation requires refrigerated storage and need to be administered with food...
Eligibility Criteria
Inclusion
- Signed informed consent
- Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA)
- Age\> 18 years
- On a standard PI containing HAART regimen with 2 NRTIs with a VL \< 50 copies for at least 12 weeks OR ARV-naive patients, or patient on a NNRTI based regimen
- Currently having no AIDS defining illness
- 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 2 x 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 excipients which may be employed in the study.
- Active drug abuse
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00802334
Start Date
January 1 2008
End Date
December 1 2011
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT
Bangkok, Thailand, 10330