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

Germans Trias i Pujol Hospital

Status and phase: Completed; Phase 4

Conditions: HIV; HIV Infections

Treatments: Drug: maraviroc; Drug: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT00966329

MARAVI-SWITCH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

to switch from the NNRTI/PI to maraviroc

Experimental group

Description:

to switch from the NNRTI/PI to maraviroc

Treatment:

Drug: maraviroc

to continue with the same approach

Active Comparator group

Description:

to continue with the same approach

Treatment:

Drug: control group