Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients
- Registration Number
- NCT04002323
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- HIV-1 infected adults (<17 y.o.)
- Antiretroviral-naïve.
- Be able to comply with protocol requirements and instructions.
- Subject or the subject's representative capable of giving signed informed consent.
- Women who are breastfeeding or plan to become pregnant during the study.
- Patients who in the investigator's judgment, poses a significant drop out risk or life expectancy inferior to study ending.
- Patients with anticipated need to change the ART before study ending.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV-1 ART-Naive Lamivudine 300 mg Lamivudine (300 mg p.o. q 24 h) plus Dolutegravir (50 mg p.o. q 24 h) HIV-1 ART-Naive Dolutegravir 50mg Tab Lamivudine (300 mg p.o. q 24 h) plus Dolutegravir (50 mg p.o. q 24 h)
- Primary Outcome Measures
Name Time Method Percentage of subjects with plasma HIV 1 RNA <50 copies/milliliter at week 48 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
Name Time Method Number of Participants Who Discontinue Treatment 48 weeks Changes from baseline in lymphocytes cell counts at week 24 and 48 Baseline, 24 weeks and 48 weeks Number of Participants With Any Adverse Event (AE) 48 weeks An AE is any untoward medical occurrence in a clinical investigation participant
Trial Locations
- Locations (24)
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Andalucía, Spain
Hospital Clínico Universitario "Virgen de la Arrixaca"
🇪🇸El Palmar, Región De Murcia, Spain
Hospital Reina Sofía
🇪🇸Murcia, Región De Murcia, Spain
Hospital Universitario Torrecárdenas
🇪🇸Almería, Spain
Hospital de Jerez
🇪🇸Cadiz, Spain
Hospital Universitario Puerto Real
🇪🇸Cadiz, Spain
Hospital Comarcal Santa Ana de Motril
🇪🇸Granada, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Comarcal de Melilla
🇪🇸Melilla, Spain
Hospital Universitario de melilla
🇪🇸Melilla, Spain
Hospital General Universitario Santa Lucía
🇪🇸Murcia, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital de Son Llàtzer
🇪🇸Palma De Mallorca, Spain
Hospital Costa del Sol
🇪🇸Málaga, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain
Hospital Universitario y Politécnico de La Fe
🇪🇸Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Marina Baixa
🇪🇸Villajoyosa, Alicante, Spain
Hospital San Pedro
🇪🇸Logroño, La Rioja, Spain
Hospital de Jaen
🇪🇸Jaén, Spain
Hospital Campus de la Salud
🇪🇸Granada, Spain