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Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3

NCT ID: NCT01235013

Last Updated: 2010-11-19

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load.

The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery.

60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. They will be randomized to either continue with its usual high activity antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of Maraviroc for HIV+ cirrhotic patients.

Detailed Description

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Conditions

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HIV-1 Infection

Keywords

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HIV-1 infection Maraviroc CD4 lymphocyte count

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maraviroc

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks

Control

Patients continue with their usual treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Maraviroc

150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* HIV infection
* Patients receiving HAART treatment for at least one year with a sustained viral load equal or below 200 copies/ml
* Viral load equal or below 200 copies/ml at the screening visit
* Discordant patients: patients without an increment over 50 copies /ml of CD4 lymphocytes during the last year
* Patients with an expected adherence to HIV treatment over 90% according to their physician.
* Signed informed consent form

Exclusion Criteria

* Pregnancy or breast feeding or women planning pregnancy during the study duration
* Any contraindication to treatment with Maraviroc
* X4 tropism at inclusion
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

Responsible Party

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Hospital Clínic i Provincial de Barcelona

Principal Investigators

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José Luis Blanco, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic i Provincial

Locations

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Hospital Clínic i Provincial

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Central Contacts

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José María Gatell, MD

Role: CONTACT

Phone: 0034932275400

Email: [email protected]

Judit Pich, Pharmacist

Role: CONTACT

Phone: 0034932275400

Email: [email protected]

Facility Contacts

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José María Gatell, MD

Role: primary

Judit Pich, Pharmacist

Role: backup

Other Identifiers

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DIS-MVC

Identifier Type: -

Identifier Source: org_study_id