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PI Vs. NNRTI Based Therapy for HIV Advanced Disease
This study is currently recruiting participants.
Verified by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, September 2006
First Received: September 7, 2005   Last Updated: September 13, 2006   History of Changes
Sponsors and Collaborators: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
National Council of Science and Technology, Mexico
Instituto Mexicano del Seguro Social
Information provided by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT00162643
  Purpose

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.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
Drug: zidovudine+lamivudine+lopinavir/ritonavir
Drug: zidovudine + lamivudine + efavirenz
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

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

Estimated Enrollment: 300
Study Start Date: December 2004
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162643

Contacts
Contact: Juan G Sierra-Madero, MD 5255-56559675 jsmadero@yahoo.com
Contact: Angelina Villasis-Keever, MD MSc 5255-56559675 avkeever@prodigy.net.mx

Locations
Mexico, D.F.
Hospital de Especialidades Centro Medico Nacional siglo XXI Recruiting
Mexico City, D.F., Mexico, 06720
Contact: Leticia M Perez-Saleme, MD     5255-56-27 69 00 ext 21547     lepesa@prodigy.net.mx    
Principal Investigator: Leticia M Perez-Saleme, MD            
Mexico, DF
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, DF, Mexico, 14000
Contact: Angelina Villasis-Keever, MD MSc     5255-56559675     avkeever@prodigy.net.mx    
Contact: Luis E. Soto-Ramirez, MD     5255-56559675     lsoto@quetzal.innsz.mx    
Principal Investigator: Angelina Villasis-Keever, MD MSc            
Sub-Investigator: Luis E Soto-Ramirez, MD            
Mexico, Estado de Mexico
Hospital General Regional #72 Recruiting
Tlalnepantla, Estado de Mexico, Mexico, 54000
Contact: Fernanda Gutierrez-Escolano, MD MSc     5255-5565 9210 ext 320     fernandamx@yahoo.com    
Contact: Pueblito Pizano-Gonzalez, MD     5255-5565 9210 ext 320        
Principal Investigator: Fernanda Gutierrez-Escolano, MD MSc            
Sub-Investigator: Pueblito Pizano-Gonzalez, MD            
Hospital General Regional #53 Recruiting
Los Reyes La Paz, Estado de Mexico, Mexico, 56400
Contact: Patricia Mendez-Cardos, MD     5255-5855 4414 ext 238     kalekbuda74@yahoo.com    
Principal Investigator: Patricia Mendez-Cardos, MD            
Mexico, Guanajuato
Hospital General Regional de Leon Recruiting
Leon, Guanajuato, Mexico
Contact: Juan L Mosqueda-Gomez, MD     5255-4771310037     luis_mosqueda@yahoo.com    
Principal Investigator: Juan L Mosqueda-Gomez, MD            
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
National Council of Science and Technology, Mexico
Instituto Mexicano del Seguro Social
Investigators
Study Chair: Juan G Sierra-Madero, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

No publications provided

Study ID Numbers: SALUD-2003-C01-123
Study First Received: September 7, 2005
Last Updated: September 13, 2006
ClinicalTrials.gov Identifier: NCT00162643     History of Changes
Health Authority: Mexico: National Council of Science and Technology

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Acquired Immunodeficiency Syndrome
Antiretroviral Therapy, Highly Active
Protease Inhibitors
Reverse Transcriptase Inhibitors

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Efavirenz
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors
Pathologic Processes
Anti-Retroviral Agents
Therapeutic Uses
Syndrome
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Disease
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on September 11, 2009