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

HIV Infections Clinical Trial

Official title:

Pilot Study to Assess the Safety and Efficacy of Switching the Nnrti or pi to Maraviroc in Hiv-1-infected Subjects With Persistent Viremia Suppression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966329
• Other study ID #: MARAVI-SWITCH
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: January 23, 2013
• Start date: October 2009
• Est. completion date: May 2012

Study information

• Verified date: January 2013
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• maraviroc
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
• 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).

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona
Spain	Lluita contra la Sida Foundation, HIV Unit	Badalona	Barcelona
Spain	Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load		48 weeks	Yes
Secondary	Time to virological failure		48 weeks	Yes
Secondary	Administration of lipid-lowering drugs		48 weeks	No
Secondary	Changes in the SCORE equation		48 weeks	No
Secondary	CD4 / CD8 cell counts		48 weeks	Yes
Secondary	Antiretroviral resistance and viral tropism		48 weeks	No
Secondary	Patients who withdraw		48 weeks	No
Secondary	Total cholesterol	Total cholesterol levels	48 weeks	Yes
Secondary	HDL-cholesterol	HDL-cholesterol levels	48 weeks	Yes
Secondary	LDL-cholesterol	LDL-cholesterol levels	48 weeks	Yes
Secondary	Triglyceride	Triglyceride levels	48 weeks	Yes