Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
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
1 other identifier
interventional
70
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedDecember 15, 2010
October 1, 2006
October 10, 2006
December 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Clinic
Barcelona, Barcelona, 08036, Spain
CSU Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Donostia Ospitaleak
Donostia / San Sebastian, Giputzkoa, 20014, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Related Publications (1)
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.
PMID: 20624069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jose M Gatell, MD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 10, 2006
First Posted
October 11, 2006
Last Updated
December 15, 2010
Record last verified: 2006-10