PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Recruitment status was Recruiting
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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 |
- Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
- 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 |
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 |
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| Contact: Juan G Sierra-Madero, MD | 5255-56559675 | jsmadero@yahoo.com |
| Contact: Angelina Villasis-Keever, MD MSc | 5255-56559675 | avkeever@prodigy.net.mx |
| 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 | |
| Study Chair: | Juan G Sierra-Madero, MD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
More Information
No publications provided
| 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 HIV Infections Immunologic Deficiency Syndromes 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 May 16, 2013