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

July 16, 2019 updated by: Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Andalucía
      • Granada, Andalucía, Spain, 18008
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Principal Investigator:
          • CARMEN HIDALGO, Dr
        • Principal Investigator:
          • JUAN PASQUAU, Dr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in lymphocytes cell counts at week 24 and 48
Time Frame: Baseline, 24 weeks and 48 weeks
Baseline, 24 weeks and 48 weeks
Number of Participants With Any Adverse Event (AE)
Time Frame: 48 weeks
An AE is any untoward medical occurrence in a clinical investigation participant
48 weeks
Number of Participants Who Discontinue Treatment
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Virgen de las Nieves

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 7, 2019

Primary Completion (ANTICIPATED)

February 28, 2021

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (ACTUAL)

June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOLAVI

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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