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Sponsors and Collaborators: |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran National Council of Science and Technology, Mexico Instituto Mexicano del Seguro Social |
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Information provided by: | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
ClinicalTrials.gov Identifier: | NCT00162643 |
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 |
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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 |
Estimated Enrollment: | 300 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Juan G Sierra-Madero, MD | 5255-56559675 | jsmadero@yahoo.com |
Contact: Angelina Villasis-Keever, MD MSc | 5255-56559675 | avkeever@prodigy.net.mx |
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 |
Study Chair: | Juan G Sierra-Madero, MD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
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 |
Acquired Immunodeficiency Syndrome Antiretroviral Therapy, Highly Active Protease Inhibitors Reverse Transcriptase Inhibitors |
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 |
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 |