Back to resultsImmunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
AZT+3TC+IDV+RTV
AZT+3TC+EFV
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive
Eligibility Criteria
Inclusion Criteria:
- Diagnosed HIV-1 infection.
- Age 18 years or over.
- No previous antiretroviral therapy.
- CD4 lymphocyte count of < 100 cells/mL.
- Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.
Exclusion Criteria:
- Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
- Currently undergoing treatment for an opportunistic infection (parenteral administration).
- Any formal contraindication to treatment with the study drugs
Sites / Locations
- CSU Bellvitge
- Donostia Ospitaleak
- Hospital de la Santa Creu i Sant Pau
- Hospital Vall d'Hebron
- Hospital Clinic
- Hospital Universitario La Paz
Outcomes
Primary Outcome Measures
Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
Secondary Outcome Measures
Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
and levels of CD8 cells (CD28+ y CD38+)
Incidence of adverse events
Full Information
NCT ID
NCT00385957
First Posted
October 10, 2006
Last Updated
December 14, 2010
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00385957
Brief Title
Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
Official Title
Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
5. Study Description
Brief Summary
The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZT+3TC+IDV+RTV
Intervention Type
Drug
Intervention Name(s)
AZT+3TC+EFV
Primary Outcome Measure Information:
Title
Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
Title
Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
Secondary Outcome Measure Information:
Title
Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
Title
CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
Title
and levels of CD8 cells (CD28+ y CD38+)
Title
Incidence of adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed HIV-1 infection.
Age 18 years or over.
No previous antiretroviral therapy.
CD4 lymphocyte count of < 100 cells/mL.
Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.
Exclusion Criteria:
Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
Currently undergoing treatment for an opportunistic infection (parenteral administration).
Any formal contraindication to treatment with the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Gatell, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
Facility Information:
Facility Name
CSU Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Donostia Ospitaleak
City
San Sebastian
State/Province
Giputzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20624069
Citation
Miro JM, Manzardo C, Pich J, Domingo P, Ferrer E, Arribas JR, Ribera E, Arrizabalaga J, Lonca M, Cruceta A, de Lazzari E, Fuster M, Podzamczer D, Plana M, Gatell JM; Advanz Study Group. Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Res Hum Retroviruses. 2010 Jul;26(7):747-57. doi: 10.1089/aid.2009.0105.
Results Reference
derived
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Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
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