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

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ClinicalTrials.gov Identifier: NCT00886990
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : May 15, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment
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

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Study Design

Study Type : Observational
Actual Enrollment : 240 participants
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
Study Start Date : October 2007
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ritonavir
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00886990


Locations
Thailand
HIV-NAT
Bangkok, Thailand, 10330
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand
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
Ministry of Education, Thailand
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:
Responsible Party: Thanyawee Puthanakit, HIV-NAT
ClinicalTrials.gov Identifier: NCT00886990     History of Changes
Other Study ID Numbers: HIV-NAT 086
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: April 2009

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:
Infection
Communicable Diseases
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
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase 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
Nucleic Acid Synthesis Inhibitors