NCT05786547 is a Phase 3 clinical trial of Varenicline in Human Immunodeficiency Virus, sponsored by University of Colorado, Denver.

Who is sponsoring NCT05786547?

NCT05786547 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT05786547?

Interventions in NCT05786547: Varenicline, Positively Smoke Free Mobile (PSF-M), Standard Care.

What condition does NCT05786547 study?

NCT05786547 studies Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco.

Is NCT05786547 still recruiting?

NCT05786547 is currently recruiting now. Last updated 15 June 2025.

Last reviewed 2025-06-15 · How we verify

NCT05786547

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

V+PSF-M for Tobacco Cessation in HIV Care in India

Recruiting now Phase 3 Last updated 15 June 2025

What this trial tests

Phase 3 trial testing Varenicline in Human Immunodeficiency Virus in 400 participants. Currently enrolling.

Timeline

2 January 2024

Primary endpoint
22 July 2026

22 July 2026

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	400
Start date	2 January 2024
Primary completion	22 July 2026
Estimated completion	22 July 2026
Sites	2 locations across United States, India

Drugs / interventions tested

Varenicline (varenicline) — full drug profile →
Positively Smoke Free Mobile (PSF-M)
Standard Care — full drug profile →

Conditions studied

Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
Smoking Cessation — all drugs for Smoking Cessation →
Smoking, Tobacco — all drugs for Smoking, Tobacco →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with Human Immunodeficiency Virus or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV). The study interventions used in this research study are: * Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program) * Varenicline (or Chantix, apovarenicline, Champix or Nocrav)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial.
Malpeddi T, Poongulali S, Shuter J, Rigotti NA, et al · · 2026 · PMID 41352530 · DOI 10.1016/j.cct.2025.108179

Verify or expand the search:

Other trials of Varenicline

Trials testing the same drug.

NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
NCT06854406 — A Study of Varenicline in the Treatment of Visceral Sensation · Phase 1 · completed
NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
NCT06029907 — Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. · Phase 4 · completed
NCT06218823 — Tobacco Treatment Comparison for Cancer Care · Phase 4 · completed

Other recruiting trials for Human Immunodeficiency Virus

Currently open trials in the same condition.

NCT07530198 — HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong · Phase 1 · recruiting
NCT06819176 — Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretrovir · Phase 1 · recruiting
NCT06408142 — Universal Test and Connect for HIV Service Delivery in South Africa · recruiting
NCT07101458 — The Eswatini PRISM Study on Adolescents Living With HIV · NA · recruiting
NCT06554223 — The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care · NA · recruiting

Other University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · 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 NCT05786547 (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 University of Colorado, Denver
Last refreshed: 15 June 2025

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/NCT05786547.

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