PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Primary Purpose
Acquired Immunodeficiency Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
zidovudine+lamivudine+lopinavir/ritonavir
zidovudine + lamivudine + efavirenz
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Immunodeficiency Syndrome focused on measuring Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Protease Inhibitors, Reverse Transcriptase Inhibitors
Eligibility Criteria
Inclusion Criteria: HIV infected individuals Men or women at least 18 years old CD4+ T cells ≤200/ml Antiretroviral naive Exclusion Criteria: 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
Sites / Locations
- Hospital de Especialidades Centro Medico Nacional siglo XXIRecruiting
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting
- Hospital General Regional #53Recruiting
- Hospital General Regional #72Recruiting
- Hospital General Regional de LeonRecruiting
Outcomes
Primary Outcome Measures
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Secondary Outcome Measures
plasma Viral Load change from baseline
Clinical symptoms
CD4 counts
Safety
Tolerability
Discontinuations
Full Information
NCT ID
NCT00162643
First Posted
September 7, 2005
Last Updated
September 13, 2006
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
National Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT00162643
Brief Title
PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Official Title
Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
National Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social
4. Oversight
5. Study Description
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.
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 suggests that the rate of response to PI based therapy may be slightly compromised if the baseline CD4 count is ≤ 200/mm3 and the plasma HIV-1-RNA ≥ 100,000 copies/mL. This may not be equally apparent if ritonavir boosted protease inhibitors are used. The effect of baseline CD4 count and HIV-1-RNA levels on the antiviral efficacy of NNRTI based regimens has been less well characterized. A significant number of patients currently initiate therapy at late stages of progression, typically with baseline CD4 count is ≤ 200/mm3. In Mexico approximately 60% of patients who initiate therapy are within this range of CD4 cell counts. Currently, the two combinations recommended as preferred are with two NRTIs and either Efavirenz or Lopinavir/ritonavir, while other combinations of PIs and ritonavir are considered alternative.
Comparison: The efficacy of ritonavir boosted protease inhibitor based therapy versus NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with a CD4 count ≤ 200/mm3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome
Keywords
Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Protease Inhibitors, Reverse Transcriptase Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zidovudine+lamivudine+lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
zidovudine + lamivudine + efavirenz
Primary Outcome Measure Information:
Title
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Secondary Outcome Measure Information:
Title
plasma Viral Load change from baseline
Title
Clinical symptoms
Title
CD4 counts
Title
Safety
Title
Tolerability
Title
Discontinuations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV infected individuals
Men or women at least 18 years old
CD4+ T cells ≤200/ml
Antiretroviral naive
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan G Sierra-Madero, MD
Phone
5255-56559675
Email
jsmadero@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Villasis-Keever, MD MSc
Phone
5255-56559675
Email
avkeever@prodigy.net.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan G Sierra-Madero, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Especialidades Centro Medico Nacional siglo XXI
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leticia M Perez-Saleme, MD
Phone
5255-56-27 69 00
Ext
21547
Email
lepesa@prodigy.net.mx
First Name & Middle Initial & Last Name & Degree
Leticia M Perez-Saleme, MD
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelina Villasis-Keever, MD MSc
Phone
5255-56559675
Email
avkeever@prodigy.net.mx
First Name & Middle Initial & Last Name & Degree
Luis E. Soto-Ramirez, MD
Phone
5255-56559675
Email
lsoto@quetzal.innsz.mx
First Name & Middle Initial & Last Name & Degree
Angelina Villasis-Keever, MD MSc
First Name & Middle Initial & Last Name & Degree
Luis E Soto-Ramirez, MD
Facility Name
Hospital General Regional #53
City
Los Reyes La Paz
State/Province
Estado de Mexico
ZIP/Postal Code
56400
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Mendez-Cardos, MD
Phone
5255-5855 4414
Ext
238
Email
kalekbuda74@yahoo.com
First Name & Middle Initial & Last Name & Degree
Patricia Mendez-Cardos, MD
Facility Name
Hospital General Regional #72
City
Tlalnepantla
State/Province
Estado de Mexico
ZIP/Postal Code
54000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Gutierrez-Escolano, MD MSc
Phone
5255-5565 9210
Ext
320
Email
fernandamx@yahoo.com
First Name & Middle Initial & Last Name & Degree
Pueblito Pizano-Gonzalez, MD
Phone
5255-5565 9210
Ext
320
First Name & Middle Initial & Last Name & Degree
Fernanda Gutierrez-Escolano, MD MSc
First Name & Middle Initial & Last Name & Degree
Pueblito Pizano-Gonzalez, MD
Facility Name
Hospital General Regional de Leon
City
Leon
State/Province
Guanajuato
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan L Mosqueda-Gomez, MD
Phone
5255-4771310037
Email
luis_mosqueda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Juan L Mosqueda-Gomez, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
24805184
Citation
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.
Results Reference
derived
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PI Vs. NNRTI Based Therapy for HIV Advanced Disease
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