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Search / Trial NCT00626301

Lopinavir/Ritonavir Monotherapy in Children

Launched by THE HIV NETHERLANDS AUSTRALIA THAILAND RESEARCH COLLABORATION · Feb 28, 2008

Trial Information

Current as of April 27, 2025

Completed

Keywords

Efficacy Safety Pharmacokinetics Lpv/R Monotherapy Thai Children Efficacy Safety Lpv/R Monotherapy Maintenance Treatment Experienced

ClinConnect Summary

The commonly used antiretroviral (ARV) regimen in the Thai National Access to Antiretroviral Program for People Living with HIV/AIDS is non-nucleoside reverse transcriptase (NNRTI) based HAART. However, one of the most challenging concerns of antiretroviral therapy is the emergence of drug resistance mutants which occurs in 30-40% of treated patients. Children failing nucleoside reverse transcriptase inhibitor (NRTI)/NNRTI regimens have limited options for second line therapy especially in a developing country such as Thailand.

At HIV-NAT, the Thai Red Cross AIDS Research Centre, we had a ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. HIV infected children ages 2 to 18 years
  • 2. Treated with double boosted PIs during the last three months
  • 3. Two consecutive plasma HIV-RNA levels \< 50 copies/ml at least 3 months apart
  • 4. Willing to restart HAART with the same regimen as before enrollment, when indicated
  • 5. Signed written informed consent
  • Exclusion Criteria:
  • 1. Active AIDS-defining disease at screening
  • 2. Pregnancy

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

Bangkok, , Thailand

Khon Kaen, , Thailand

Patients applied

0 patients applied

Trial Officials

Praphan Phanuphak, MD, PhD

Principal Investigator

HIV-NAT, Thai Red Cross - AIDS Research Centre

Pope Kosalaraksa, MD

Principal Investigator

Department of Pediatrics, Khon Kaen University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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