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

September 7, 2005
September 13, 2006
December 2004
Not Provided
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Same as current
Complete list of historical versions of study NCT00162643 on ClinicalTrials.gov Archive Site
  • plasma Viral Load change from baseline
  • Clinical symptoms
  • CD4 counts
  • Safety
  • Tolerability
  • Discontinuations
Same as current
Not Provided
Not Provided
 
PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acquired Immunodeficiency Syndrome
  • Drug: zidovudine+lamivudine+lopinavir/ritonavir
  • Drug: zidovudine + lamivudine + efavirenz
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2007
Not Provided

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
Both
18 Years and older
No
Contact: Juan G Sierra-Madero, MD 5255-56559675 jsmadero@yahoo.com
Contact: Angelina Villasis-Keever, MD MSc 5255-56559675 avkeever@prodigy.net.mx
Mexico
 
NCT00162643
SALUD-2003-C01-123
Not Provided
Not Provided
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • National Council of Science and Technology, Mexico
  • Instituto Mexicano del Seguro Social
Study Chair: Juan G Sierra-Madero, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP