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Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

NCT ID: NCT00386659

Last Updated: 2006-10-11

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tenofovir + abacavir + lopinavir/ritonavir

Intervention Type DRUG

tenofovir + abacavir + efavirenz

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-infection
* Antiretroviral-naive
* CD4 cell count below 100 cells/mm3

Exclusion Criteria

* Pregnancy
* Current opportunistic infection requiring parenteral therapy
* Current malignancies requiring parenteral chemotherapy
* Any contraindication to 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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Josep M Gatell, MD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

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Hospital de 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

Countries

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Spain

Other Identifiers

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ADVAN-Z-2

Identifier Type: -

Identifier Source: org_study_id