REal-Life Cohort With DOlutegravir + LAmivudina

  • STATUS
    Recruiting
  • End date
    Jan 15, 2022
  • participants needed
    200
  • sponsor
    Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Updated on 14 April 2021

Summary

Since 1996, HAART based on 3-drug regimens (3DR) in people living with HIV (PLHIV) has decreased mortality and today, PLHIV have a life expectancy close to that of the general population. In the last decade new drugs have improved tolerance and posology of these treatment. However PLHIV needs to continue the treatment and will likely remain on antiviral therapy for many years. In the recent period, active research is being sought with the aim of improving the dosage and reducing the amount of drugs necessary to maintain efficacy, to avoid the possible cumulative effects of long-term antiretroviral therapy (ART). Two-drug regimens (2DRs) have been investigated as a means for reducing the number of antiretroviral agents (ARVs) taken by individuals who need lifelong ART. Dovato (Dolutegravir/lamivudine) has been evaluated in two phase III studies (GEMINI-1 and GEMINI-2) in treatment-naive adults achieving non inferiority according to the US Food and Drug Administration (FDA) Snapshot algorithm. These data led to the approval of the fixed-dose combination of dolutegravir/lamivudine as a once-daily, single-tablet 2DR by the FDA and the European Medicines Agency. Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato as an initial treatment in HIV-nave patients. However there is no real- life cohort data. Our aim is to provide information related to effectiveness and tolerability/safety in nave patients when used in routine clinical practice. It has been already published results from the phase III study in pretreatment adult patients.

Our results in real life have encouraged us to conduct a multicenter cohort study in patients who have already started their first antiretroviral therapy with dolutegravir (DTG) + lamivudine (3TC), to verify efficacy and tolerance in real life. Our hypothesis is that the data will be similar to those reported in clinical trials.

Description

Our primary objective of this study is to analyze the proportion of individuals (HIV nave patients) who has initiated 3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h), and who achieve viral suppression (HIV-1 RNA 50 copies/mL) at weeks 48.

Secondary objectives are: to analyze the proportion of individuals who achieve viral suppression (HIV-1 RNA 50 copies/mL) at weeks 24 and 96, to describe absolute values and changes from ART initiation in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks, Changes from ART initiation in creatinine clearance anda fasting lipids at weeks 24, 48 and 96, and the proportion of subjects who discontinue treatment and reasons for discontinuations

Details
Condition HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection, HIV-1-infection
Treatment Dolutegravir 50 mg, Lamivudine 300 MG
Clinical Study IdentifierNCT04638686
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient 18 years of age diagnosed with HIV
Nave antiretroviral treatment with dolutegravir/lamivudine initiated between July 2018 and March 2020
Patients who agree to participate and sign the informed consent form of the study
Patients lost to follow up or died prior to the inclusion in the study (Ethics Committee agreement for exemption from obtaining informed consent in these cases)

Exclusion Criteria

Patient < 18 years of age
Patients who don't agree to participate and don't sign the informed consent
Current pregnancy or breastfeeding
No effective contraception for FRP women
Evidence of DTG or 3TC resistance genotype
Hepatitis B (HBV) infection
Severe hepatic impairment or unstable liver disease
Moderate to severe renal impairment
AIDS defining illness
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