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

NCT ID: NCT04002323

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2022-03-31

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.

Conditions

HIV-1-infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV-1 ART-Naive

Lamivudine (300 mg p.o. q 24 h) plus Dolutegravir (50 mg p.o. q 24 h)

Dolutegravir 50mg Tab

Intervention Type: DRUG

The subjects starts their ART with this drugs, once a day

Lamivudine 300 mg

Intervention Type: DRUG

The subjects starts their ART with this drugs, once a day

Interventions

Dolutegravir 50mg Tab

The subjects starts their ART with this drugs, once a day

Intervention Type: DRUG

Lamivudine 300 mg

The subjects starts their ART with this drugs, once a day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: lead

Responsible Party

Carmen Hidalgo Tenorio

SPECIALIST PHYSICIAN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

Hospital Universitario Virgen de Las Nieves

Granada, Andalusia, Spain

Hospital San Pedro

Logroño, La Rioja, Spain

Hospital Clínico Universitario "Virgen de la Arrixaca"

El Palmar, Murcia, Spain

Hospital Reina Sofía

Murcia, Murcia, Spain

Hospital Universitario Torrecárdenas

Almería, , Spain

Hospital de Jerez

Cadiz, , Spain

Hospital Universitario Puerto Real

Cadiz, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Campus de la Salud

Granada, , Spain

Hospital Comarcal Santa Ana de Motril

Granada, , Spain

Hospital de Jaen

Jaén, , Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, , Spain

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Costa del Sol

Málaga, , Spain

Hospital Comarcal de Melilla

Melilla, , Spain

Hospital Universitario de melilla

Melilla, , Spain

Hospital General Universitario Santa Lucía

Murcia, , Spain

Hospital de Son Llàtzer

Palma de Mallorca, , Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital Universitario y Politécnico de La Fe

Valencia, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Countries

Spain

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Other Identifiers

DOLAVI

Identifier Type: -

Identifier Source: org_study_id