Private medical center started Real-life Cohort Study in Antiretroviral Treatment-naive Adults With HIV-1 Infection
Photo by Markus Spiske
The Fundacion Jimenez Diaz University Hospital (Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz) is enrolling patients into the clinical trial investigating REal-Life Cohort With DOlutegravir + LAmivudina (REDOLA).
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.
The aim of this study 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.
The trial is designed to enroll male and female 18 years and older who are diagnosed with HIV and is being conducted in Madrid, Spain.
The study start date is June 15, 2020.
Among the exclusion criteria are:
- 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
The Fundacion Jimenez Diaz University Hospital (formerly Clínica de la Concepción) is a private medical center with a public concert located in Madrid belonging to the Quirónsalud Group.
It was inaugurated on July 1, 1955 by the doctor Carlos Jiménez Díaz as "Clínica de la Concepción", public-private management.1 Located on Avenida de los Reyes Católicos, next to Plaza de Cristo Rey, in the district from Moncloa-Aravaca, at present the center maintains its concert with the Madrid Health Service (SERMAS), of which it is a reference hospital.
This page provides a more detailed overview of this clinical trial:
