NCT04884139CompletedPhase 4
DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:
DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: an Open-label Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
The hypothesize that DTG/3TC will be non-inferior to BIC/FTC/TAF with a 4% margin in virologically suppressed HIV-infected patients. The study will allow claiming for Superiority. Assuming that both DTG and BIC may lead to similar weight gains (approximately 1 kg after 48 weeks) in virologically suppressed HIV-infected patients and that TAF may induce a further weight gain (approximately 1 kg after 48 weeks), also hypothesize that switching to BIC/FTC/TAF may lead to greater weight gain than switching to DTG/3TC over 48 weeks. This trial is a Phase IV, open-label, randomized multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in HIV patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 554 (actual)
- First submitted
- 5 May 2021
- Start date
- 14 Jul 2021
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Diseases
- HIV
- NCT number
- NCT04884139
- EU CT number
- 2024-515167-56-00
- EudraCT number
- 2020-003686-18
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 554
- From 14 Jul 2021 to the primary completion date, 20 Feb 2024
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current therapy with dolutegravir or bictegravir.
- Any recently (\<=6 months) diagnosed clinical condition or recently (\<=6 months) initiated concomitant therapy (see Section 6.5) that may primarily affect weight or body composition. E.g., including but not limited to endocrine disorders, osteoporosis or medications to treat these clinical conditions, with the exception of ontrolled diabetes mellitus.
Other illness
- Evidence of Hepatitis B virus infection based on at least one positive result of testing at Screening for Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (anti- HBc).
- History of allergy to study drugs or their components.
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert\'s syndrome or asymptomatic gallstones);
- Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification and/or anticipated need for Hep C treatment.
- Kidney disease as defined by CKD-EPI \<50ml/min.
Lab values
- Liver disease as defined by ALT \>= 5x ULN or ALT \>=3xULN and Bili =1.5xULN (with \>35% direct bilirubin).
Other
- Is pregnant or lactating at the screening visit or at any time during the study or is planning on becoming pregnant over the duration of the study.
Who the study is looking for
- Understanding the study information provided and being capable of giving written informed consent.
- Confirmed HIV infection.
- ≥18 years of age on the day of screening.
- HIV RNA \<50 copies/mL for at least 24 weeks before screening.
- Receiving any regimen for HIV containing more than 1 pill a day or any single tablet regimen containing at least one of the following: cobicistat-boosting, efavirenz, or tenofovir disoproxyl fumarate, for at least 24 weeks before screeningPatients with TAF are expected from cobiscitat-boosting single tablet regimens containing darunavir or elvitegravir and from more-than-1-pill-a-day regimens containing TAF/FTC; their participation will be limited to ≤25%. Patients will be stratified according to the presence or not of TAF in their regimens.
- No evidence of previous viral failure.
- No known or suspected resistance to study drugs.
- Females of childbearing potential, must be using highly effective methods of contraception from study inclusion and for at least 4 weeks after last study visit; all female volunteers must be willing to undergo urine pregnancy testing at the time points specified in the schedules of events.
- Clinical stability: Participants who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Completed |
| Hospital Universitario De Guadalajara SESCAM Coordinator of this site? Confirm its status | Guadalajara | Spain | Completed |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Completed |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Completed |
| Hospital Universitario Reina Sofía de Murcia Coordinator of this site? Confirm its status | Murcia | Spain | Completed |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Completed |
| Parc Sanitari Sant Joan de Déu Coordinator of this site? Confirm its status | Sant Boi de Llobregat | Spain | Completed |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitari Joan XXIII de Tarragona Coordinator of this site? Confirm its status | Tarragona | Spain | Completed |
| Hospital Clínico de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Completed |
| Hospital Marina Baixa De La Vila Joiosa Coordinator of this site? Confirm its status | Villajoyosa | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.