'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    1
  • sponsor
    ViiV Healthcare
Updated on 23 April 2022
antiretroviral
antiretroviral agents
antiretroviral therapy
reverse transcriptase inhibitor
dolutegravir
integrase inhibitors
lamivudine
HIV Vaccine

Summary

Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.

Details
Condition HIV Infections
Treatment Dolutegravir (DTG), Lamivudine (3TC), Rilpivirine (RPV)
Clinical Study IdentifierNCT04019873
SponsorViiV Healthcare
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment

Exclusion Criteria

No specific exclusion criteria
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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