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

NCT00886990 | Completed

• 1 other identifier: HIV-NAT 086
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

HIV Infection; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml over a 48-week period.

  48 weeks

Secondary Outcomes (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

  48 weeks

Study Arms (2)

1

Receiving a single PI boosted by low dose ritonavir

Drug: ritonavir-boosted PI-based second line treatments

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

Interventions

ritonavir-boosted PI-based second line treatments DRUG

single PI boosted by low dose ritonavir

1

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

2

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Children (\< 18 years old) with HIV infection
• Have failed NNRTI-based ART
• 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)
• Began ritonavir-boosted PI prior to June 30, 2007

You may not qualify if:

• Have previously received PI treatment for longer than 30 days prior to the current PI regimen.
• Has previously or currently been treated with abacavir or tenofovir
• Currently on ART other than NRTI, NNRTI and PI drug classes

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Ministry of Education, Thailand: collaborator

Study Sites (8)

Petchburi Hospital

Petchburi, Petchburi, Thailand

Location

HIV-NAT

Bangkok, 10330, Thailand

Location

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Location

Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Department of Pediatrics, Faculty of Medicine, Chiang Mai University Hospital

Chiang Mai, Thailand

Location

Chiang Rai Regional Hospital

Chiang Rai, Thailand

Location

Khon Kaen University

Khon Kaen, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, Thailand

Location

Related Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (8)