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

NCT01034917 | Completed Phase 3

• 1 other identifier: ETRA-SWITCH
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Viral load

  week 48 after baseline

Secondary Outcomes (8)

• CD4+/CD8+ T lymphocytes count

  evolution from baseline to week 48

• Genotypic test

  if virologic failure occurs

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

  evolution from baseline to week 48

• Administration of lipid-lowering drugs throughout the study

  from baseline to week 48

• Cardiovascular risk assessed by the SCORE equation

  evolution from baseline to week 48

Study Arms (2)

Etravirine group

EXPERIMENTAL

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

Drug: Etravirine 400 mg dissolved in water every 24 hours

Control group

ACTIVE COMPARATOR

Continue with the same antiretroviral regimen

Drug: Continue with the same antiretroviral regimen

Interventions

Etravirine 400 mg dissolved in water every 24 hours DRUG

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

Also known as: ETV

Etravirine group

Continue with the same antiretroviral regimen DRUG

Continue with the same antiretroviral regimen

Also known as: CNT

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Pregnancy or fertile women willing to be pregnant.
• Clinically significant malabsorption syndrome within 30 days prior to randomization.
• (B) Small blips that are preceded or forwarded by 2 undetectable viral loads will not be taken in care.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Germans Trias i Pujol University Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

• 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.

  PMID: 24503952 DERIVED

MeSH Terms

Interventions

etravirine

Study Officials

• Eugenia Negredo, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra. Eugenia Negredo Puigmal

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

ES (1)