NCT05735535 (Woddol4455) is a Phase 3 clinical trial of Antiviral Agents in HIV Infections, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Who is sponsoring NCT05735535?

NCT05735535 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT05735535?

Interventions in NCT05735535: Antiviral Agents.

What condition does NCT05735535 study?

NCT05735535 studies HIV Infections.

Is NCT05735535 still recruiting?

NCT05735535 is currently status unknown. Last updated 13 September 2023.

Last reviewed 2023-09-13 · How we verify

NCT05735535: Woddol4455

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

Women in Dual With Dolutegravir

Status unknown Phase 3 Last updated 13 September 2023

What this trial tests

Phase 3 trial testing Antiviral Agents in HIV Infections in 290 participants. Status unknown.

Timeline

1 October 2023

Primary endpoint
15 September 2025

15 September 2025

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	290
Start date	1 October 2023
Primary completion	15 September 2025
Estimated completion	15 September 2025
Sites	1 location across Italy

Drugs / interventions tested

Antiviral Agents — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Eligibility, female only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Strategies for optimizing antiretroviral treatment in virologically suppressed patients are still a major challenge in the field of HIV. These strategies include improving the toxicity and tolerability of drugs in the short and long term, such as replacing toxic agents with safer ones or reducing the number of drugs in the combination. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that is converted intracellularly to the active form, resulting in higher concentrations of TFV diphosphate in circulating lymphocytes than those obtained with tenofovir disoproxil fumarate (TDF). Because of these pharmacokinetic properties, TAF results in 91% lower plasma exposure to TFV. Phase 3 studies have established the virological noninferiority of TAF to TDF, with a lower frequency of renal and bone adverse events. Replacing TDF with TAF may be a safe and effective option to reduce toxicities when switching from one ARV strategy to another and, to date, could represent the optimization of a three-drug regimen. Dolutegravir (DTG) is a potent INSTI that exhibits rapid and potent viral load reduction and a high barrier to resistance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Antiviral Agents

Trials testing the same drug.

NCT05013632 — COVID-19 International Drug Pregnancy Registry · recruiting
NCT05317260 — Steatohepatitis in Chronic Hepatitis B · completed

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting

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 NCT05735535 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 13 September 2023

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/NCT05735535.

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