Efficacy and Safety of Single Versus Double Ritonavir-Boosted Protease Inhibitor (PI)-Based Antiretroviral Therapy (ART) Regimens

This study has been completed.
Sponsor:
Collaborator:
The Commission on Higher Education, Ministry of Education
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00886990
First received: April 22, 2009
Last updated: May 14, 2009
Last verified: April 2009
  Purpose

The virological efficacy will be no different in children treated with single versus double boosted PI second line ART regimens.


Condition Intervention
HIV Infection
HIV Infections
Drug: ritonavir-boosted PI-based second line treatments
Drug: two PIs boosted by low dose ritonavir or one PI plus full dose ritonavir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparing the Efficacy and Safety of Single Versus Double Ritonavir-Boosted Protease Inhibitor (PI)-Based Antiretroviral Therapy (ART) Regimens for Children Failing Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Treatment

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml over a 48-week period. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HIV/AIDS disease progression, changes in CD4+ cell count or percentage, treatment failure, antiretroviral drug resistance, serious adverse events, grade 3 or grade 4 events, and toxicities [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Receiving a single PI boosted by low dose ritonavir
Drug: ritonavir-boosted PI-based second line treatments
single PI boosted by low dose ritonavir
2
Receiving two PIs boosted by low dose ritonavir or one PI plus full dose ritonavir
Drug: two PIs boosted by low dose ritonavir or one PI plus full dose ritonavir
two PIs boosted by low dose ritonavir or one PI plus full dose ritonavir

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Data of children who satisfy the following eligibility criteria will be included.

Criteria

Inclusion Criteria:

  1. Children (< 18 years old) with HIV infection
  2. Have failed NNRTI-based ART
  3. Received second-line regimen with either one or two boosted PIs (Note: low dose ritonavir to boost the other PI will not be count as additional PI)
  4. Began ritonavir-boosted PI prior to June 30, 2007

Exclusion Criteria:

  1. Have previously received PI treatment for longer than 30 days prior to the current PI regimen.
  2. Has previously or currently been treated with abacavir or tenofovir
  3. Currently on ART other than NRTI, NNRTI and PI drug classes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886990

Locations
Thailand
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand
HIV-NAT
Bangkok, Thailand, 10330
Department of Pediatrics, Faculty of Medicine, Chiang Mai University Hospital
Chiang Mai, Thailand
Chiang Rai Regional Hospital
Chiang Rai, Thailand
Khon Kaen University
Khon Kaen, Thailand
Bamrasnaradura Institute
Nonthaburi, Thailand
Petchburi Hospital
Petchburi, Thailand
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
The Commission on Higher Education, Ministry of Education
Investigators
Principal Investigator: Thanyawee Puthanakit, MD The HIV Netherlands Australia Thailand Research Collaboration
Principal Investigator: Jintanat Ananworanich, MD, Ph.D The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) and South East Asia Research Collaboration with Hawaii (SEARCH), The Thai Red Cross AIDS Research Centre, Bangkok
  More Information

Additional Information:
No publications provided

Responsible Party: Thanyawee Puthanakit, HIV-NAT
ClinicalTrials.gov Identifier: NCT00886990     History of Changes
Other Study ID Numbers: HIV-NAT 086
Study First Received: April 22, 2009
Last Updated: May 14, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
single- and double-boosted PI
second line regimen
NNRTI failure
HIV-infected children
Compare virological efficacy and safety of single- or double-boosted PI regimens as second line therapy in children with NNRTI-based treatment failure
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Ritonavir
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014