PI Vs. NNRTI Based Therapy for HIV Advanced Disease

NCT ID: NCT00162643

Last Updated: 2006-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-12-31

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.

Conditions

Acquired Immunodeficiency Syndrome

Keywords

Acquired Immunodeficiency Syndrome; Antiretroviral Therapy, Highly Active; Protease Inhibitors; Reverse Transcriptase Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

zidovudine+lamivudine+lopinavir/ritonavir

Intervention Type: DRUG

zidovudine + lamivudine + efavirenz

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Principal Investigators

Juan G Sierra-Madero, MD

Role: STUDY_CHAIR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

Hospital de Especialidades Centro Medico Nacional siglo XXI

Mexico City, D.F., Mexico

Site Status: RECRUITING

Hospital General Regional de Leon

León, Guanajuato, Mexico

Site Status: RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, Mexico

Site Status: RECRUITING

Hospital General Regional #53

Los Reyes Acaquilpan, State of Mexico, Mexico

Site Status: RECRUITING

Hospital General Regional #72

Tlalnepantla, State of Mexico, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Juan G Sierra-Madero, MD

Role: CONTACT

Phone: 5255-56559675

Email: jsmadero@yahoo.com

Angelina Villasis-Keever, MD MSc

Role: CONTACT

Phone: 5255-56559675

Email: avkeever@prodigy.net.mx

Facility Contacts

Leticia M Perez-Saleme, MD

Role: primary

Juan L Mosqueda-Gomez, MD

Role: primary

Angelina Villasis-Keever, MD MSc

Role: primary

Luis E. Soto-Ramirez, MD

Role: backup

Patricia Mendez-Cardos, MD

Role: primary

Fernanda Gutierrez-Escolano, MD MSc

Role: primary

Pueblito Pizano-Gonzalez, MD

Role: backup

References

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.

Reference Type: DERIVED

PMID: 24805184 (View on PubMed)

Other Identifiers

SALUD-2003-C01-123

Identifier Type: -

Identifier Source: org_study_id