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TDM of Generic Lopinavir/Ritonavir 200/50 mg

NCT00802334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-07-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

generic lopinavir/ritonavir

1. Screening visit • Clinical and safety laboratory assessment. Viral load for patients on a PI-based regimen, if a VL results ≤ 3 months is not available 2. Baseline visit • (Within 30 days after screening) Baseline clinical and laboratory assessment, patients who were on a Kaletra SGC formulation before baseline will undergo TDM. Start generic lopinavir/ritonavir tablets 200/50 in a 400/100mg bid dosage. Backbone will be chosen on the discretion of the study physician 3. Week 4 * Steady state TDM lopinavir and ritonavir, at 10-12 hr after the last intake (Cmin) Clinical, safety and laboratory assessment Week 12: Clinical, safety and efficacy laboratory assessment Week 24: Clinical, safety and efficacy laboratory assessment Week 48: Clinical, safety and efficacy laboratory assessment

Sponsors & Collaborators

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Anchalee Avihingsanon, MD, PhD · HIV-NAT, Thai Red Cross - AIDS Research Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00802334 on ClinicalTrials.gov