REal-Life Cohort With DOlutegravir + LAmivudina (REDOLA)
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| ClinicalTrials.gov Identifier: NCT04638686 |
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Recruitment Status :
Recruiting
First Posted : November 20, 2020
Last Update Posted : April 6, 2021
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV-1-infection | Drug: Dolutegravir 50 MG Drug: Lamivudine 300 MG |
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
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study |
| Actual Study Start Date : | June 15, 2020 |
| Estimated Primary Completion Date : | June 15, 2021 |
| Estimated Study Completion Date : | January 15, 2022 |
- Drug: Dolutegravir 50 MG
The subjects started their antiretroviral treatment containing dolutegravir once a day.
- Drug: Lamivudine 300 MG
The subjects started their antiretroviral treatment containing lamivudine once a day
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
This is an open, multicenter and prospective cohort of HIV-infected adult patients who have initiated Dolutegravir/lamivudine as first line treatment for HIV-1 infection prior to be included in study. We hope to include 200 patients. Patient management will be according to the standard of care.
We will collect data related to efficacy, tolerance, and discontinuations due any reasons (lost to follow-up, withdrawal of consent, switching,..).
We will carry out an analysis by intention to treat according to the snapshot criteria defined by the FDA ±12 weeks window in the context of routine clinical practice (±2 weeks in w-4 analysis), considering as virological failure those patients who discontinue the treatment for any reason, loss to follow-up, withdraw informed consent or those who die for causes unrelated to the treatment
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638686
| Spain | |
| Alfonso Cabello | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: Alfonso Cabello, MD, PhD +34 915504800 ext +34 915504800 acabello@fjd.es | |
| Responsible Party: | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| ClinicalTrials.gov Identifier: | NCT04638686 |
| Other Study ID Numbers: |
IFJD-DOL-20-01 |
| First Posted: | November 20, 2020 Key Record Dates |
| Last Update Posted: | April 6, 2021 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Infections Lamivudine Dolutegravir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents HIV Integrase Inhibitors Integrase Inhibitors |