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Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100

NCT ID: NCT00385957

Last Updated: 2010-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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Conditions

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HIV Infections

Keywords

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Treatment Naive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AZT+3TC+IDV+RTV

Intervention Type DRUG

AZT+3TC+EFV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Principal Investigators

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Jose M Gatell, MD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status

Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

CSU Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Donostia Ospitaleak

Donostia / San Sebastian, Giputzkoa, Spain

Site Status

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 20624069 (View on PubMed)

Other Identifiers

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ADVAN-Z

Identifier Type: -

Identifier Source: org_study_id