NCT04638686: REDOLA

REal-Life Cohort With DOlutegravir + LAmivudina

Completed Last updated 14 November 2023

What this trial tests

trial testing Dolutegravir 50 MG in HIV-1-infection in 185 participants. Completed in 31 March 2022.

Timeline

15 June 2020

Primary endpoint
15 June 2021

31 March 2022

Quick facts

Lead sponsor	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Status	Completed
Study type	OBSERVATIONAL
Enrollment	185
Start date	15 June 2020
Primary completion	15 June 2021
Estimated completion	31 March 2022
Sites	1 location across Spain

Drugs / interventions tested

• Dolutegravir 50 MG — full drug profile →
• Lamivudine 300 MG — full drug profile →

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz — full company profile →

Who can join

18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 48-Week effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort.
   Cabello-Ubeda A, de Quirós JCLB, Martín Carbonero L, Sanz J, et al · · 2022 · cited 13× · PMID 36409695 · DOI 10.1371/journal.pone.0277606