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NCT01172535 · ClinicalTrials.gov registry record · Phase 2
A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines
A Phase 2 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
- 19
- Study locations
NCT01172535: Completed Phase 2 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01172535 is a Phase 2 study of HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 97 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (78% lower). The trial reports 19 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172535, a Phase 2 study of HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
- 19
- Study locations
Study Summary
Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to infant drug resistance, this dosing is often complicated and impractical in busy clinical settings. To address this, the World Health Organization (WHO) has released a simplified dosing table based on infant weight bands. This study will evaluate the absorption, safety, and tolerance of LPV/r in infants when dosed according to the new WHO guidelines.
Primary Outcome
Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir
Conditions Studied
Interventions
- DRUG Lopinavir/ritonavir
Study Locations (19)
Other
- Hospital Federal dos Servidores do Estado NICHD CRS - Rio de Janeiro
- Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS - Rio de Janeiro
- Hosp. Geral De Nova Igaucu Brazil NICHD CRS - Rio de Janeiro
- Inst de Infectologia Emilio Ribas Sao Paulo Brazil NICHD CRS - São Paulo
- Univ. of Sao Paulo Brazil NICHD CRS - São Paulo
- Prapokklao Hosp. CRS - Chanthaburi
- Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS - Chiang Mai
- Chiangrai Prachanukroh Hospital CRS - Chiangrai
- Chonburi Hosp. CRS - Chon Buri
- Phayao Provincial Hosp. CRS - Phayao
California
- University of California, UC San Diego CRS - La Jolla
Colorado
- Univ. of Colorado Denver NICHD CRS - Aurora
Massachusetts
- Boston Medical Center Ped. HIV Program NICHD CRS - Boston
Minas Gerais
- SOM Federal University Minas Gerais Brazil NICHD CRS - Belo Horizonte
Rio Grande do Sul
- Hosp. Santa Casa Porto Alegre Brazil NICHD CRS - Porto Alegre
Gauteng
- Shandukani CRS - Johannesburg
Western Cape
- Family Clinical Research Unit (FAM-CRU) CRS - Tygerberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01172535 record still lists
NCT01172535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (78% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Lopinavir/ritonavir is the first listed.
NCT01172535 lists 19 locations in 10 states (Other, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT01172535 about?
NCT01172535 is a clinical study titled "A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines". Treatment of children and infants with HIV requires modification of medication dosing according to a child's specific weight. For lopinavir/ritonavir (LPV/r), a second line treatment option that is increasingly necessary due to infant drug resistance, this dosing is often complicated and impractical...
What is the current status of trial NCT01172535?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2010-11. Estimated completion is 2013-12.
What conditions does trial NCT01172535 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01172535?
The interventions under investigation include: Lopinavir/ritonavir (DRUG).
Who is sponsoring clinical trial NCT01172535?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01172535 being conducted?
This trial has 19 study locations across California, Colorado, Massachusetts, Minas Gerais, Rio Grande do Sul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01172535's enrollment target sits among peer trials
97 163rd of 303 higher than 140 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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