- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034917
Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression
Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Etravirine in HIV-1-infected Subjects With Viremia Suppression
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The aim of the study is to compare the virological efficacy of the etravirine-based regimen with standard PI-containing regimen.
Study Overview
Status
Conditions
Detailed Description
Etravirine is a second generation non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) approved by the U.S. Food and Drug Administration (FDA) in January 2008 and by the European Medicines Agency in September 2008 for clinical use in adults with incomplete virologic suppression and resistance to previous NNRTI and other antiretroviral classes.
A question that has not been explored is whether subjects with sustained undetectable HIV-1 RNA-levels experiencing antiretroviral-related toxicity can safely switch their current PI to etravirine. This treatment strategy could allow improvements in tolerability and lipid profile and would permit an easy posology (400 mg dissolved in water every 24 hours). We designed a proof-of-concept study to test the efficacy and safety of switching from a Protease Inhibitor (PI) to etravirine in subjects with viral suppression as an antiretroviral strategy of simplification therapy, based on the high antiviral potency, low toxicity, together with its easy posology (in water dissolution).
Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach.
The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Germans Trias i Pujol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patient having a diagnosis of HIV-1 infection.
- Antiretroviral therapy started at least 12 months before, always with a HAART combination including 2 NRTIs plus a PI.
- Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) since the beginning of antiretroviral therapy, for at least 6 months.
- Absence of suspected or documented resistance mutations in the RT associated to NNRTIs or to any NRTI.
Patient having at least one of the following conditions:
- Dyslipemia (LDL cholesterol >130 mg/dL or triglycerides > 350 mg/dL) derived from their current PI regimen or current use of lipid-lowering agents due to dyslipemia,
- Antiretroviral-related gastrointestinal disturbances, or
- Low patient's satisfaction associated with the current regimen posology (BID regimen, ritonavir use, ritonavir intolerance…).
- Good treatment adherence.
- Voluntary written informed consent.
Exclusion Criteria:
- Previous therapy with mono or dual antiretroviral therapies after initial of HAART era.
- Previous antiretroviral treatment failures, treatment interruptions (A) or blips (B) in viral load (VL > 50 copies/mL).
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
- Clinically significant malabsorption syndrome within 30 days prior to randomization.
(A) Patients who in the past made any interruption of treatment (provide that it has not been in the last year) may be considered candidates for the study, if they meet other criteria for inclusion, since the break in the treatment should not assume the emergence of mutations.
(B) Small blips that are preceded or forwarded by 2 undetectable viral loads will not be taken in care.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Etravirine group
To switch from the PI to Etravirine 400 mg dissolved in water every 24 hours
|
Switch from the PI to Etravirine 400 mg dissolved in water every 24 hours
Other Names:
|
Active Comparator: Control group
Continue with the same antiretroviral regimen
|
Continue with the same antiretroviral regimen
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Viral load
Time Frame: week 48 after baseline
|
week 48 after baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD4+/CD8+ T lymphocytes count
Time Frame: evolution from baseline to week 48
|
evolution from baseline to week 48
|
Genotypic test
Time Frame: if virologic failure occurs
|
if virologic failure occurs
|
Lipid profile: total, HDL-, LDL-cholesterol and triglyceride levels
Time Frame: evolution from baseline to week 48
|
evolution from baseline to week 48
|
Administration of lipid-lowering drugs throughout the study
Time Frame: from baseline to week 48
|
from baseline to week 48
|
Cardiovascular risk assessed by the SCORE equation
Time Frame: evolution from baseline to week 48
|
evolution from baseline to week 48
|
Patient's satisfaction assessed by 2 scales of type Likert
Time Frame: evolution from baseline to week 48
|
evolution from baseline to week 48
|
Adverse events related to antiretroviral treatment
Time Frame: from baseline to week 48
|
from baseline to week 48
|
Etravirine plasma trough concentration
Time Frame: Week 4
|
Week 4
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eugenia Negredo, MD,PhD, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Viremia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Etravirine
- Anti-Retroviral Agents
Other Study ID Numbers
- ETRA-SWITCH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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