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Search / Trial NCT00887120

Dose Reduction of Lopinavir in Children

Launched by THE HIV NETHERLANDS AUSTRALIA THAILAND RESEARCH COLLABORATION · Apr 22, 2009

Trial Information

Current as of May 27, 2025

Completed

Keywords

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.

ClinConnect Summary

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 o...

Gender

ALL

Eligibility criteria

  • 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.

About The Hiv Netherlands Australia Thailand Research Collaboration

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) is a leading international clinical trial sponsor dedicated to advancing research in HIV prevention, treatment, and care. Established through a partnership between renowned institutions in the Netherlands, Australia, and Thailand, HIV-NAT focuses on innovative, evidence-based strategies to improve health outcomes for diverse populations affected by HIV. By fostering collaborative research initiatives, the organization aims to generate impactful data that informs clinical practices and public health policies, ultimately contributing to the global fight against HIV/AIDS.

Locations

Bangkok, , Thailand

Patients applied

0 patients applied

Trial Officials

Kiat Ruxrungtham, MD

Principal Investigator

Department of Medicine, Faculty of Medicine, Chulalongkorn University and Thai Red Cross Aids Research Centre - HIV-NAT

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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