Status:
UNKNOWN
PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Instituto Mexicano del Seguro Social
Conditions:
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Detailed Description
Current guidelines for initial therapy in HIV infection recommend 2 NRTIs plus either a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor (NNRTI). Recent data su...
Eligibility Criteria
Inclusion
- HIV infected individuals
- Men or women at least 18 years old
- CD4+ T cells ≤200/ml
- Antiretroviral naive
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00162643
Start Date
December 1 2004
End Date
December 1 2007
Last Update
September 14 2006
Active Locations (5)
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1
Hospital de Especialidades Centro Medico Nacional siglo XXI
Mexico City, D.F., Mexico, 06720
2
Hospital General Regional de Leon
León, Guanajuato, Mexico
3
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico, 14000
4
Hospital General Regional #53
Los Reyes Acaquilpan, State of Mexico, Mexico, 56400