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

NCT03369743 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2020-05-20

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Romain Palich, MD · Pitié-Salpêtrière Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2018-06-30
Completion
2019-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369743 on ClinicalTrials.gov