Status:
COMPLETED
Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
HIV
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 maravir...
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 follow...
Eligibility Criteria
Inclusion
- HIV-1 infected adults (=/+18 years old).
- 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.
- Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART.
- 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.
- Nadir CD4 cell count \> 350 cells/mm3.
- Absence of resistance mutations in the RT or PR by (TrugeneTM)
- Good treatment adherence.
- Voluntary written informed consent.
Exclusion
- Virologic failure to a previous antiretroviral regimen.
- Any antiretroviral resistance mutation in a previous resistance test.
- 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.
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00966329
Start Date
October 1 2009
End Date
May 1 2012
Last Update
January 24 2013
Active Locations (3)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation
Badalona, Barcelona, Spain, 08916
3
Lluita contra la Sida Foundation, HIV Unit
Badalona, Barcelona, Spain, 08916