TDM of Generic Lopinavir/Ritonavir 200/50 mg

NCT00802334 | Completed Phase 2

• 2 other identifiers: HIV-NAT 095IRB414/50
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

generic lopinavir/ritonavir; therapeutic drug monitoring; safety and efficacy

Outcome Measures

Primary Outcomes (1)

• To determine the Cmin levels of the generic lopinavir/ritonavir tablets 200/50 mg in Thai HIV-infected patients

  18 months

Secondary Outcomes (1)

• To assess 48 weeks safety and tolerability of the generic lopinavir tablets 200/50 mg for the standard dosing regimen

  24 months

Study Arms (1)

1

EXPERIMENTAL

Drug: generic lopinavir/ritonavir

Interventions

generic lopinavir/ritonavir DRUG

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

1

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
• 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

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 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• The Government Pharmaceutical Organization: collaborator

Study Sites (1)

HIV-NAT

Bangkok, 10330, Thailand

Location

Related Publications (2)

• Ramautarsing RA, van der Lugt J, Gorowara M, Sophonphan J, Ananworanich J, Lange JM, Burger DM, Phanuphak P, Ruxthungtham K, Avihingsanon A. Pharmacokinetics and 48-week safety and efficacy of generic lopinavir/ritonavir in Thai HIV-infected patients. Antivir Ther. 2013;18(2):249-52. doi: 10.3851/IMP2324. Epub 2012 Aug 23.

  PMID: 22908131 RESULT

• van der Lugt J, Lange J, Avihingsanon A, Ananworanich J, Sealoo S, Burger D, Gorowara M, Phanuphak P, Ruxrungtham K. Plasma concentrations of generic lopinavir/ritonavir in HIV type-1-infected individuals. Antivir Ther. 2009;14(7):1001-4. doi: 10.3851/IMP1410.

  PMID: 19918104 DERIVED

Related Links

• HIV-NAT's website

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anchalee Avihingsanon, MD, PhD

  HIV-NAT, Thai Red Cross - AIDS Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: December 4, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)