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

Phase 4

Completed

• Conditions: HIV; HIV Infections
• Interventions: Drug: maraviroc; Drug: control group

• Registration Number: NCT00966329
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Study Start: 2009-10
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
to switch from the NNRTI/PI to maraviroc	maraviroc	to switch from the NNRTI/PI to maraviroc
to continue with the same approach	control group	to continue with the same approach

Primary Outcome Measures

Name	Time	Method
Viral load	48 weeks

Secondary Outcome Measures

Name	Time	Method
Time to virological failure	48 weeks
Administration of lipid-lowering drugs	48 weeks
Changes in the SCORE equation	48 weeks
CD4 / CD8 cell counts	48 weeks
Antiretroviral resistance and viral tropism	48 weeks
Patients who withdraw	48 weeks
Total cholesterol	48 weeks	Total cholesterol levels
HDL-cholesterol	48 weeks	HDL-cholesterol levels
LDL-cholesterol	48 weeks	LDL-cholesterol levels
Triglyceride	48 weeks	Triglyceride levels

Trial Locations

Locations (3)

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, Spain