PI Vs. NNRTI Based Therapy for HIV Advanced Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
First received: September 7, 2005
Last updated: September 13, 2006
Last verified: September 2006
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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         
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         
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 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 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00162643     History of Changes
Other Study ID Numbers: SALUD-2003-C01-123
Study First Received: September 7, 2005
Last Updated: September 13, 2006
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

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

ClinicalTrials.gov processed this record on August 28, 2014