Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-05-31

Brief Summary

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Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

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Detailed Description

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This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.

Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).

Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.

The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.

Conditions

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HIV HIV Infections

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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to switch from the NNRTI/PI to maraviroc

Group Type EXPERIMENTAL

maraviroc

Intervention Type DRUG

HAART regimen including 2 NRTI/NtRTIs plus maraviroc

to continue with the same approach

Group Type ACTIVE_COMPARATOR

control group

Intervention Type DRUG

HAART regimen including 2 NRTI/NtRTIs plus one of the following :

* 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir)
* or ATV/unboosted (in a regimen without tenofovir)
* or 1 NNRTI (nevirapine or efavirenz).

Interventions

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maraviroc

HAART regimen including 2 NRTI/NtRTIs plus maraviroc

Intervention Type DRUG

control group

HAART regimen including 2 NRTI/NtRTIs plus one of the following :

* 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir)
* or ATV/unboosted (in a regimen without tenofovir)
* or 1 NNRTI (nevirapine or efavirenz).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. HIV-1 infected adults (=/+18 years old).
2. Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
3. Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART.
4. Patient having at least one of the following conditions:

* Antiretroviral-related gastrointestinal disturbances, or
* Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance…), or
* Any toxicity drug related.
5. Nadir CD4 cell count \> 350 cells/mm3.
6. Absence of resistance mutations in the RT or PR by (TrugeneTM)
7. Good treatment adherence.
8. Voluntary written informed consent.

Exclusion Criteria

1. Virologic failure to a previous antiretroviral regimen.
2. Any antiretroviral resistance mutation in a previous resistance test.
3. Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
4. Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
5. Pregnancy or fertile women willing to be pregnant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No