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Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients (DOLAVI)

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ClinicalTrials.gov Identifier: NCT04002323
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves

Brief Summary:

Thanks to the actual highly active antiretroviral therapy (HAART) patients living with HIV have a better life expectancy, becoming chronical patients. Today's antiretroviral treatment (ART) must be maintained for life to prevent disease progression until a cure is reached. Given this need, ARTs are becoming safer and more effective but are still toxic. Cause of that simplification therapies are real, reducing the number of different Antiretrovirals involved controlling the infection. This strategies include from monotherapy using/with protease inhibitors (PI), which was investigated with treatment-experienced patients and virologically suppressed, to dual therapies which recently were investigated in treatment-naïve and treatment-experienced patients with combinations such as dolutegravir (DTG) plus lamivudine (3TC), Dolutegravir plus rilpivirine or rilpivirine plus darunavir/ritonavir boosted.

Nowadays dual therapy in real life (not into the context of a clinical trial) with dolutegravir plus lamivudine is largely studied in treatment-experienced patients who are virologically suppressed and got nearly a 100% efficacy results. Recently published results from clinical trials in treatment-naïve patients GEMINI 1 &2, where efficacy of the dual therapy with DTG 50mg plus 3TC 300mg/QD was compared versus the efficacy of triple therapy with tenofovir disoproxil fumarate, emtricitabine and dolutegravir (TDF/FTC+ DTG) (QD). Both trials show similar efficacy results, with virologic suppression higher than 90% at week 48.

Clinical trials are the gold standard to approve and add to the clinical practice new drugs and new therapies, but is also known that have some inconvenient like strict inclusion-exclusion criteria which put the study population far from being a real sample. Studies with real world data (RWD) have several strengths such as quality in medical attention and works like a bridge between clinical trials and standard clinical care, reducing/lowering general costs, improving results and accelerating the generation of knowledge.

For all the reasons above, the primary objective of this study is to analyze in treatment-naïve HIV patients the effectiveness in real life of 3TC (300 mg p.o. q 24 h) plus DTG (50 mg p.o. q 24 h). Secondary objectives are: to describe the patient who receive this dual therapy, to quantify the time gap between the clinic visit and the first dose of dual therapy administrated evaluating this dual therapy as candidate to "test and treat" therapies; to analyze the viral load drop and the increase of cluster of differentiation 4 (CD4) T lymphocytes levels; To analyze virological failures and previous mutations influence in basal resistance tests; and finally a pharmacoeconomic analysis, safety of the treatment and adherence to the healthcare system.


Condition or disease Intervention/treatment
HIV-1-infection Drug: Dolutegravir 50mg Tab Drug: Lamivudine 300 mg

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 139 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 48 Weeks
Official Title: Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV-1 ART-Naive
Lamivudine (300 mg p.o. q 24 h) plus Dolutegravir (50 mg p.o. q 24 h)
Drug: Dolutegravir 50mg Tab
The subjects starts their ART with this drugs, once a day

Drug: Lamivudine 300 mg
The subjects starts their ART with this drugs, once a day




Primary Outcome Measures :
  1. Percentage of subjects with plasma HIV 1 RNA <50 copies/milliliter at week 48 [ Time Frame: 48 weeks ]
    The proportion of subjects with viral suppression (HIV-1 RNA <50 copies/mL) among subjects who received at least one dose of study medication


Secondary Outcome Measures :
  1. Changes from baseline in lymphocytes cell counts at week 24 and 48 [ Time Frame: Baseline, 24 weeks and 48 weeks ]
  2. Number of Participants With Any Adverse Event (AE) [ Time Frame: 48 weeks ]
    An AE is any untoward medical occurrence in a clinical investigation participant

  3. Number of Participants Who Discontinue Treatment [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study will be conducted in approximately 139 HIV-1 infected, ART-naive adults who began their ART with DTG 50mg plus 3TC 300mg , without limits of viral load or CD4 lymphocytes recount at screening.

The following population will be assessed:

Intent-to-treat (ITT) Population: This population will consist of all randomized subjects who receive at least one dose of study medication.

Intent-to-treat modified (ITT-m) Population: this population will consist of subjects in the ITT Population with the exception of mild protocol violators, those who discontinue for reasons other than those related to treatment (such as adverse events, tolerability or lack of efficacy).

Per protocol (PP) Population: This population will consist of subjects in the ITT Population with exception of major protocol violators, such as violations which could affect the assessment of antiviral activity.

Criteria

Inclusion Criteria:

  1. HIV-1 infected adults (<17 y.o.)
  2. Antiretroviral-naïve.
  3. Be able to comply with protocol requirements and instructions.
  4. Subject or the subject's representative capable of giving signed informed consent.

Exclusion Criteria:

  1. Women who are breastfeeding or plan to become pregnant during the study.
  2. Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
  3. Patients with anticipated need to change the ART before study ending.

Information from the National Library of Medicine

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): NCT04002323


Contacts
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Contact: CARMEN HIDALGO, Dr +34 958 895 414 CHIDALGO72@GMAIL.COM
Contact: SERGIO SEQUERA, Ph +34 958 895 414 SERGIOSEQUERA@GMAIL.COM

Locations
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Spain
Hospital Universitario Virgen de Las Nieves Recruiting
Granada, Andalucía, Spain, 18008
Contact: SERGIO SEQUERA, Ph    +34 958 895 414    SERGIOSEQUERA@GMAIL.COM   
Principal Investigator: CARMEN HIDALGO, Dr         
Principal Investigator: JUAN PASQUAU, Dr         
Sponsors and Collaborators
University Hospital Virgen de las Nieves
Publications:

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Responsible Party: Carmen Hidalgo Tenorio, SPECIALIST PHYSICIAN, University Hospital Virgen de las Nieves
ClinicalTrials.gov Identifier: NCT04002323    
Other Study ID Numbers: DOLAVI
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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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
Additional relevant MeSH terms:
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Lamivudine
Dolutegravir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors