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Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression

Primary Purpose

HIV

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Etravirine 400 mg dissolved in water every 24 hours

Continue with the same antiretroviral regimen

About this trial

This is an interventional treatment trial for HIV focused on measuring Active Comparator, Placebo Comparator, Sham Comparator, No intervention, Other, Treatment Experienced

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Germans Trias i Pujol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Etravirine group

Control group

Arm Description

To switch from the PI to Etravirine 400 mg dissolved in water every 24 hours

Continue with the same antiretroviral regimen

Outcomes

Primary Outcome Measures

Viral load

Secondary Outcome Measures

CD4+/CD8+ T lymphocytes count

Genotypic test

Lipid profile: total, HDL-, LDL-cholesterol and triglyceride levels

Administration of lipid-lowering drugs throughout the study

Cardiovascular risk assessed by the SCORE equation

Patient's satisfaction assessed by 2 scales of type Likert

Adverse events related to antiretroviral treatment

Etravirine plasma trough concentration

Full Information

NCT ID

NCT01034917

First Posted

December 17, 2009

Last Updated

January 30, 2020

Sponsor

Germans Trias i Pujol Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01034917

Brief Title

Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression

Official Title

Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Etravirine in HIV-1-infected Subjects With Viremia Suppression

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Germans Trias i Pujol Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV

Keywords

Active Comparator, Placebo Comparator, Sham Comparator, No intervention, Other, Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Etravirine group

Arm Type

Experimental

Arm Description

To switch from the PI to Etravirine 400 mg dissolved in water every 24 hours

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Continue with the same antiretroviral regimen

Intervention Type

Drug

Intervention Name(s)

Etravirine 400 mg dissolved in water every 24 hours

Other Intervention Name(s)

ETV

Intervention Description

Switch from the PI to Etravirine 400 mg dissolved in water every 24 hours

Intervention Type

Drug

Intervention Name(s)

Continue with the same antiretroviral regimen

Other Intervention Name(s)

CNT

Intervention Description

Continue with the same antiretroviral regimen

Primary Outcome Measure Information:

Title

Viral load

Time Frame

week 48 after baseline

Secondary Outcome Measure Information:

Title

CD4+/CD8+ T lymphocytes count

Time Frame

evolution from baseline to week 48

Title

Genotypic test

Time Frame

if virologic failure occurs

Title

Lipid profile: total, HDL-, LDL-cholesterol and triglyceride levels

Time Frame

evolution from baseline to week 48

Title

Administration of lipid-lowering drugs throughout the study

Time Frame

from baseline to week 48

Title

Cardiovascular risk assessed by the SCORE equation

Time Frame

evolution from baseline to week 48

Title

Patient's satisfaction assessed by 2 scales of type Likert

Time Frame

evolution from baseline to week 48

Title

Adverse events related to antiretroviral treatment

Time Frame

from baseline to week 48

Title

Etravirine plasma trough concentration

Time Frame

Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugenia Negredo, MD,PhD

Organizational Affiliation

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Germans Trias i Pujol University Hospital

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24503952

Citation

Echeverria P, Bonjoch A, Puig J, Molto J, Paredes R, Sirera G, Ornelas A, Perez-Alvarez N, Clotet B, Negredo E. Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study. PLoS One. 2014 Feb 4;9(2):e84676. doi: 10.1371/journal.pone.0084676. eCollection 2014.

Results Reference

derived

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Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression

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