PI Vs. NNRTI Based Therapy for HIV Advanced Disease

September 13, 2006 updated by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • D.f.
      • Mexico City, D.f., Mexico, 06720
        • Recruiting
        • Hospital de Especialidades Centro Medico Nacional siglo XXI
        • Contact:
        • Principal Investigator:
          • Leticia M Perez-Saleme, MD
    • DF
      • Mexico City, DF, Mexico, 14000
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angelina Villasis-Keever, MD MSc
        • Sub-Investigator:
          • Luis E Soto-Ramirez, MD
    • Estado de Mexico
      • Los Reyes La Paz, Estado de Mexico, Mexico, 56400
        • Recruiting
        • Hospital General Regional #53
        • Contact:
        • Principal Investigator:
          • Patricia Mendez-Cardos, MD
      • Tlalnepantla, Estado de Mexico, Mexico, 54000
        • Recruiting
        • Hospital General Regional #72
        • Contact:
        • Contact:
          • Pueblito Pizano-Gonzalez, MD
          • Phone Number: 320 5255-5565 9210
        • Principal Investigator:
          • Fernanda Gutierrez-Escolano, MD MSc
        • Sub-Investigator:
          • Pueblito Pizano-Gonzalez, MD
    • Guanajuato
      • Leon, Guanajuato, Mexico
        • Recruiting
        • Hospital General Regional de Leon
        • Contact:
        • Principal Investigator:
          • Juan L Mosqueda-Gomez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks

Secondary Outcome Measures

Outcome Measure
Safety
Tolerability
CD4 counts
Clinical symptoms
plasma Viral Load change from baseline
Discontinuations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators

Instituto Mexicano del Seguro Social
National Council of Science and Technology, Mexico

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

September 14, 2006

Last Update Submitted That Met QC Criteria

September 13, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALUD-2003-C01-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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