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PI Vs. NNRTI Based Therapy for HIV Advanced Disease

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ClinicalTrials.gov Identifier: NCT00162643
Recruitment Status : Unknown
Verified September 2006 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : September 14, 2006
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

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date September 14, 2006
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • plasma Viral Load change from baseline
  • Clinical symptoms
  • CD4 counts
  • Safety
  • Tolerability
  • Discontinuations
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PI Vs. NNRTI Based Therapy for HIV Advanced Disease
Official Title  ICMJE Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acquired Immunodeficiency Syndrome
Intervention  ICMJE
  • Drug: zidovudine+lamivudine+lopinavir/ritonavir
  • Drug: zidovudine + lamivudine + efavirenz
Study Arms  ICMJE Not Provided
Publications * 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;17:18617. doi: 10.7448/IAS.17.1.18617. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 7, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162643
Other Study ID Numbers  ICMJE SALUD-2003-C01-123
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators  ICMJE
  • National Council of Science and Technology, Mexico
  • Instituto Mexicano del Seguro Social
Investigators  ICMJE
Study Chair: Juan G Sierra-Madero, MD Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
PRS Account Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Verification Date September 2006

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