Dose Reduction of Lopinavir in Children
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ClinicalTrials.gov Identifier: NCT00887120 |
Recruitment Status
:
Completed
First Posted
: April 23, 2009
Last Update Posted
: April 23, 2009
|
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To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children.
To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI naïve HIV-1 infected Thai children
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Lopinavir/ritonavir standard dose According to WHO simplified dosing table Drug: Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table) | Phase 2 |
In 2002, the Thai Ministry of Public Health (MOPH) launched the National Access to Antiretroviral Program for People living with HIV/AIDS (NAPHA) with the aim of providing treatment to all Thai patients who needed antiretroviral treatment. By the end of 2005, 80,000 HIV-infected Thais were treated in the NAPHA program, including about 6,000 children. The antiretroviral treatment regimen consists of three antiretroviral drugs (ARV). The first-line regimen used in NAPHA are mainly generic drugs produced by Thai government pharmaceutical organization (GPO), including a fixed-drug combination of stavudine, lamivudine, and nevirapine (GPOvir);and a fixed-drug combination of zidovudine, lamivudine, and nevirapine (GPOvir-Z). Majority of patients respond very well with first-line regimen(1,2), however about 15% of patients have drug resistance to first-line regimen and require second-line regimen(3). The protease inhibitors (PIs) is used as a second-line regimen, however there are limitations in terms of cost and metabolic complications(4).
Lopinavir/ritonavir is the most widely use protease inhibitors in children because of its high efficacy and a syrup formulation that easy to use in small children. There is evidence supported that the recommended dose according to US-FDA or EU guidelines resulting in much higher plasma blood level in Thai children. Data from 19 Thai children demonstrated Cmin of 5.9 mg/L compare to 3.4 mg/L in US children when use the same dose (the minimum acceptable Cmin is 1.0 mg/L) (5,6). There is a study HIVNAT019, which demonstrated acceptable LPV plasma concentration and treatment outcome in Thai HIV-infected adult when use reduced dose of LPV/r 266mg/66 mg compare to standard dose of 400mg/100mg (7).
Therefore, the study of pharmacokinetic of low dose of LPV/r in Thai HIV-infected children is very important to assess the safety and efficacy of this strategy. This will lead to appropriate ARV dose in children to reduce long-term adverse events, and also reduce the ARV cost.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pharmacokinetics and Efficacy of Low- or Standard-Dose of Lopinavir/Ritonavir (Kaletra®) in PI-naïve HIV-1 Infected Children |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Lopinavir/ritonavir standard dose + zidovudine and lamivudine
|
Drug: Lopinavir/ritonavir standard dose According to WHO simplified dosing table
Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r) |
Active Comparator: 2
Lopinavir/ritonavir low dose (70% of standard dose) + zidovudine and lamivudine
|
Drug: Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)
Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r) |
- pharmacokinetics of standard vs low dose LPV/r [ Time Frame: 4 weeks after start ART ]
- efficacy and safety of standard and low dose LPV/r [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age from 2- 18 years old
- Documented positive test for HIV-1 infection
- PI-naïve
- HIV RNA viral load > 1,000 copies
- Written informed consent
Exclusion Criteria:
- Active opportunistic infection
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir
- Pregnancy or lactating
- Inability to understand the nature and extent of the study and the procedures required.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887120
Thailand | |
HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Kiat Ruxrungtham, MD | Department of Medicine, Faculty of Medicine, Chulalongkorn University and Thai Red Cross Aids Research Centre - HIV-NAT |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kiat Ruxrungtham, Department of Medicine, Faculty of Medicine, Chulalongkorn University and Thai Red Cross Aids Research Centre - HIV-NAT |
ClinicalTrials.gov Identifier: | NCT00887120 History of Changes |
Other Study ID Numbers: |
HIV-NAT045 |
First Posted: | April 23, 2009 Key Record Dates |
Last Update Posted: | April 23, 2009 |
Last Verified: | April 2009 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
Second line treatment therapeutic drug monitoring Asia LPV |
children pharmacokinetic To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in Protease inhibitor (PI)- naive HIV-1 infected Thai patients. To study clinical and immunological efficacy after 48-weeks of lopinavir/ritonavir-based antiretroviral therapy in PI naive HIV-1 infected Thai patients. |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Lamivudine Zidovudine Lamivudine, zidovudine drug combination |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |