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Completed

NCT Number: NCT04638686

REal-Life Cohort With DOlutegravir + LAmivudina

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-naÏve patients. However there is no real- life cohort data. Our aim is to provide information related to effectiveness and tolerability/safety in naïve 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.

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alfonso Cabello

Madrid, 28040, Spain

About this study

Our primary objective of this study is to analyze the proportion of individuals (HIV naïve 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ≥ 18 years of age diagnosed with HIV.
  • Naïve 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

Treatment and study plan

Dolutegravir 50 mg

Drug

The subjects started their antiretroviral treatment containing dolutegravir once a day.

Lamivudine 300 mg

Drug

The subjects started their antiretroviral treatment containing lamivudine once a day

Primary outcomes

  1. Proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 48

    Time frame: 48 weeks

    HIV-1 RNA ≤50 copies/mL at 48 weeks

Secondary outcomes

  1. Proportion of individuals who achieve viral suppression (HIV-1 RNA ≤50 copies/mL) at weeks 24 and 96

    Time frame: weeks 24 and 96

    HIV-1 RNA ≤50 copies/mL at 24 and 96 weeks

  2. Absolute values and changes from ART initiation in CD4+ cells count at 24, 48 and 96 weeks

    Time frame: weeks 24, 48 and 96

    CD4 (cel/μL) at weeks 0, 24,48 and 96

  3. Absolute values and changes from ART initiation in CD4:CD8 ratio at 24, 48 and 96

    Time frame: weeks 24, 48 and 96

    CD4/CD8 (ratio) at weeks 0, 24,48 and 96

  4. Changes from ART initiation in creatinine clearance at weeks 24, 48 and 96.

    Time frame: weeks 24, 48 and 96

    creatinine clearance (mg/dL) at weeks 0, 24, 48 and 96.

  5. Changes from ART initiation in fasting lipids (total cholesterol, HDL cholesterol, LDL) cholesterol, triglycerides and ratio of total cholesterol to HDL cholesterol) at weeks 24, 48 and 96

    Time frame: weeks 24, 48 and 96

    total cholesterol, HDL cholesterol, LDL (mg/dL) at weeks 0, 24, 48 and 96.

  6. Proportion of subjects who discontinue treatment and reasons for discontinuations

    Time frame: weeks 48 and 96

    number of subjects who discontinue treatment and reasons for these discontinuations

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study title

Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study

Acronym: REDOLA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 20, 2020
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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