NCT03539224 is a Phase 2 clinical trial of Dolutegravir (DTG) in HIV-1-infection, sponsored by Instituto de Investigación Hospital Universitario La Paz.

Who is sponsoring NCT03539224?

NCT03539224 is sponsored by Instituto de Investigación Hospital Universitario La Paz.

What drugs are being tested in NCT03539224?

Interventions in NCT03539224: Dolutegravir (DTG), Lamivudine (3TC).

What condition does NCT03539224 study?

NCT03539224 studies HIV-1-infection.

Is NCT03539224 still recruiting?

NCT03539224 is currently status unknown. Last updated 7 July 2020.

Last reviewed 2020-07-07 · How we verify

NCT03539224

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.

Status unknown Phase 2 Last updated 7 July 2020

What this trial tests

Phase 2 trial testing Dolutegravir (DTG) in HIV-1-infection in 41 participants. Status unknown.

Timeline

2 November 2017

Primary endpoint
31 May 2021

31 July 2021

Quick facts

Lead sponsor	Instituto de Investigación Hospital Universitario La Paz
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	2 November 2017
Primary completion	31 May 2021
Estimated completion	31 July 2021
Sites	2 locations across Spain

Drugs / interventions tested

Dolutegravir (DTG) — full drug profile →
Lamivudine (3TC) — full drug profile →

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

18 and older, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase IIa, open clinical trial, pilot, single arm and proof of concept.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO).
De Miguel R, Rial-Crestelo D, Dominguez-Dominguez L, Montejano R, et al · · 2020 · cited 29× · PMID 32408111 · DOI 10.1016/j.ebiom.2020.102779
Long-term Evaluation of Residual Viremia in a Clinical Trial of Dolutegravir Plus Lamivudine as Maintenance Treatment for Participants With and Without Prior Lamivudine Resistance.
De Miguel Buckley R, Rial-Crestelo D, Montejano R, Pinto A, et al · · 2022 · cited 9× · PMID 36447613 · DOI 10.1093/ofid/ofac610

Verify or expand the search:

Other trials of Dolutegravir (DTG)

Trials testing the same drug.

NCT06787976 — Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Ant · Phase 4 · not yet recruiting
NCT04518228 — Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum · completed
NCT04272242 — Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals · Phase 2 · terminated
NCT04019873 — 'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors · completed
NCT02831673 — An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtr · Phase 3 · completed

Other recruiting trials for HIV-1-infection

Currently open trials in the same condition.

NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
NCT06919016 — A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1- · Phase 1 · active not recruiting
NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV · Phase 2 · recruiting
NCT06774872 — Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Succes · Phase 2 · recruiting
NCT06890988 — Ending the Epidemic Interventions in the Dental Setting - UH3 · NA · recruiting

Other Instituto de Investigación Hospital Universitario La Paz trials

Trials by the same sponsor.

NCT06709469 — Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescent · Phase 1 · recruiting
NCT06701825 — Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus · Phase 4 · recruiting
NCT06488898 — Abdominal Aortic Aneurysm Stabilization With Truncal Cells: Controlled Clinical Trial With Historical Cohorts · Phase 2 · recruiting
NCT06273306 — Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC) · NA · not yet recruiting
NCT06302647 — Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03539224 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Instituto de Investigación Hospital Universitario La Paz
Last refreshed: 7 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03539224.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing