Clinical trial NCT00385957: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Treatment Naive
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
measure: Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
Secondary outcomes:
measure: Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
measure: CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
measure: and levels of CD8 cells (CD28+ y CD38+)
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: CSU Bellvitge
state: Barcelona
city: San Sebastian
country: Spain
facility: Donostia Ospitaleak
state: Giputzkoa
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose M Gatell, MD
role: STUDY_CHAIR
References:
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.