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

Further Study Details: 

Primary Outcomes: Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Secondary Outcomes: plasma Viral Load change from baseline; Clinical symptoms; CD4 counts; Safety; Tolerability; Discontinuations
Expected Total Enrollment:  300

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 above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00162643

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

Mexico, D.F.
      Hospital de Especialidades Centro Medico Nacional siglo XXI, Mexico City,  D.F.,  06720,  Mexico; Recruiting
Mexico, DF
      Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City,  DF,  14000,  Mexico; Recruiting
Mexico, Estado de Mexico
      Hospital General Regional #72, Tlalnepantla,  Estado de Mexico,  54000,  Mexico; Recruiting
      Hospital General Regional #53, Los Reyes La Paz,  Estado de Mexico,  56400,  Mexico; Recruiting
Mexico, Guanajuato
      Hospital General Regional de Leon, Leon,  Guanajuato,  Mexico; Recruiting

Study chairs or principal investigators

Juan G Sierra-Madero, MD,  Study Chair,  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran   

Study ID Numbers:  SALUD-2003-C01-123
Last Updated:  September 12, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00162643
Health Authority: Mexico: National Council of Science and Technology
ClinicalTrials.gov processed this record on 2005-09-13