Dual Therapy Etravirine + Raltegravir by Once Daily in HIV-positive Patients (ETRAL QD)

NCT03369743 | Completed DMC

• 1 other identifier: CREPATS 007
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of etravirin + raltegravir dual therapy was showed in the ANRS 153 ETRAL protocol, in HIV-1 seropositive patients. The use of these two drugs avoids the use of nucleoside reverse transcriptase inhibitors and protease inhibitors, with a real benefit in older patients, who increasingly present contraindications to these drugs' families. The disadvantage of this strategy is twice daily (BID). Pharmacological data suggest that etravirine once a day and raltegravir once a day may provide the same virological efficacy. The objective of our study is to evaluate the ability of ETRAL QD (etravirine 400 mg x1/day + raltegravir 800 mg x1/day) to maintain virologic success at week 48 (W48), after switch, in HIV-patients under ETRAL BID (etravirine 200 mg x2/day + raltegravir 400 mg x2/day). Virological success is defined as absence of virological failure, and virological failure is defined as two consecutive plasma viral loads \>50 cp/ml over 2-4 weeks, or one plasma viral load \>400 cp/ml. This study will be a multicentric data collection. Data will be collected at W0 (patient characteristics, plasma viral load) and then at W4, W12, W24 and W48 (plasma viral load). If stopping strategy, the reason for stopping will be documented. 125 patients will be included in the six participating centers. Data will be centralized at Pitié-Salpêtrière hospital, Paris, with an anonymized e-CRF.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Measure of plasma viral load to assess the effectiveness of the dual Etral Qd to maintain the virological success to W48

  Measure ol plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)

  12 months

Eligibility Criteria

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

Study Population

HIV-patients under ETRAL BID (etravirine 200 mg x2/day + raltegravir 400 mg x2/day) This study will be a multicentric data collection. Data will be collected at W0 (patient characteristics, plasma viral load) and then at W4, W12, W24 and W48 (plasma viral load)

You may qualify if:

• HIV-1 infected adult
• Treatment by ETRAL BID (etravirine 200 mg x 2/day + raltegravir 400 mg x 2/day) for at least 96 weeks
• plasma Viral Load \< 50 cp/ml the day of the switch for ETRAL QD

You may not qualify if:

• Virologic failure under ETRAL BID (two consecutive plasma Viral Load \< 50 cp/ml)
• Applies contraindicated with etravirine
• Current pregnancy or pregnancy desire

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Yasmine Dudoit

Paris, 75013, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Romain Palich, MD

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: January 2, 2018
• Primary Completion: June 30, 2018
• Study Completion: December 30, 2019
• Last Updated: May 20, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)