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Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
This study has been completed.
Sponsor:
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
Sílvia Gel, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00966329
First received: August 25, 2009
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV HIV Infections | Drug: maraviroc Drug: control group | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sílvia Gel, Germans Trias i Pujol Hospital:
Primary Outcome Measures:
- Viral load [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
- Time to virological failure [ Time Frame: 48 weeks ]
- Administration of lipid-lowering drugs [ Time Frame: 48 weeks ]
- Changes in the SCORE equation [ Time Frame: 48 weeks ]
- CD4 / CD8 cell counts [ Time Frame: 48 weeks ]
- Antiretroviral resistance and viral tropism [ Time Frame: 48 weeks ]
- Patients who withdraw [ Time Frame: 48 weeks ]
- Total cholesterol [ Time Frame: 48 weeks ]Total cholesterol levels
- HDL-cholesterol [ Time Frame: 48 weeks ]HDL-cholesterol levels
- LDL-cholesterol [ Time Frame: 48 weeks ]LDL-cholesterol levels
- Triglyceride [ Time Frame: 48 weeks ]Triglyceride levels
| Enrollment: | 30 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: to switch from the NNRTI/PI to maraviroc
to switch from the NNRTI/PI to maraviroc
|
Drug: maraviroc
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
|
|
Active Comparator: to continue with the same approach
to continue with the same approach
|
Drug: control group
HAART regimen including 2 NRTI/NtRTIs plus one of the following :
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966329
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966329
Locations
| Spain | |
| Germans Trias i Pujol Hospital | |
| Badalona, Barcelona, Spain, 08916 | |
| Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation | |
| Badalona, Barcelona, Spain, 08916 | |
| Lluita contra la Sida Foundation, HIV Unit | |
| Badalona, Barcelona, Spain, 08916 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
| Principal Investigator: | Eugènia Negredo, MD,PhD | Lluita contra la Sida Foundation, HIV Unit |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sílvia Gel, Dra. Eugenia Negredo, Germans Trias i Pujol Hospital |
| ClinicalTrials.gov Identifier: | NCT00966329 History of Changes |
| Other Study ID Numbers: |
MARAVI-SWITCH |
| Study First Received: | August 25, 2009 |
| Last Updated: | January 23, 2013 |
Keywords provided by Sílvia Gel, Germans Trias i Pujol Hospital:
|
Switching Maraviroc Virological efficacy Lipid profile Tropism |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Maraviroc |
Protease Inhibitors Reverse Transcriptase Inhibitors CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on July 26, 2017