PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
1 other identifier
interventional
300
1 country
5
Brief Summary
Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with CD4 counts ≤ 200/mm3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2004
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedSeptember 14, 2006
September 1, 2006
September 7, 2005
September 13, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Secondary Outcomes (6)
plasma Viral Load change from baseline
Clinical symptoms
CD4 counts
Safety
Tolerability
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected individuals
- Men or women at least 18 years old
- CD4+ T cells ≤200/ml
- Antiretroviral naive
You may not qualify if:
- Suspected or documented active, untreated HIV 1 related opportunistic infection (OI) or other condition requiring acute therapy (e.g., hepatitis C virus infection)
- Platelet count \< 75,000 cells/mm3.
- Hemoglobin \< 9 g/dL .
- AST and/or ALT greater than 5 times the upper limit of normal
- Documented or suspected active tuberculosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hospital de Especialidades Centro Medico Nacional siglo XXI
Mexico City, D.F., 06720, Mexico
Hospital General Regional de Leon
León, Guanajuato, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000, Mexico
Hospital General Regional #53
Los Reyes Acaquilpan, State of Mexico, 56400, Mexico
Hospital General Regional #72
Tlalnepantla, State of Mexico, 54000, Mexico
Related Publications (1)
Lima VD, Sierra-Madero J, Wu Z, Singer J, Wood E, Hull MW, Richard Harrigan P, Montaner JS. Comparing the efficacy of efavirenz and boosted lopinavir using viremia copy-years. J Int AIDS Soc. 2014 May 6;17(1):18617. doi: 10.7448/IAS.17.1.18617. eCollection 2014.
PMID: 24805184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Juan G Sierra-Madero, MD
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 13, 2005
Study Start
December 1, 2004
Study Completion
December 1, 2007
Last Updated
September 14, 2006
Record last verified: 2006-09