NCT04638686

REal-Life Cohort With DOlutegravir + LAmivudina

Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 185 (actual)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-06-15
• Completion: 2022-03-31
• First posted: 2020-11-20
• Last updated: 2023-11-14

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study