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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Treatments: Maraviroc; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

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.