NCT00824421 is a Phase 2 clinical trial of UK-453, 061 in HIV-1, sponsored by Pfizer.

Who is sponsoring NCT00824421?

NCT00824421 is sponsored by Pfizer.

What drugs are being tested in NCT00824421?

Interventions in NCT00824421: UK-453, 061, UK-453, 061, EFV +TVA.

Is NCT00824421 still recruiting?

NCT00824421 is currently completed. Last updated 9 December 2013.

Are results published for NCT00824421?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-12-09 · How we verify

NCT00824421

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

A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects

Completed Phase 2 Results posted Last updated 9 December 2013

What this trial tests

Phase 2 trial testing UK-453, 061 in HIV-1 in 195 participants. Completed in 1 October 2011.

Timeline

1 February 2009

Primary endpoint
1 October 2011

1 October 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	195
Start date	1 February 2009
Primary completion	1 October 2011
Estimated completion	1 October 2011
Sites	31 locations across Argentina, Australia, Canada, Italy, Mexico, Poland, South Africa, Switzerland

Drugs / interventions tested

UK-453, 061 — full drug profile →
UK-453, 061 — full drug profile →
EFV +TVA — full drug profile →

Conditions studied

HIV-1 — all drugs for HIV-1 →

Sponsor

Pfizer — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48
Time frame: Week 48
Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.

Sponsor's own description

This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Publications & conference data

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

Effects of ketoconazole and valproic acid on the pharmacokinetics of the next generation NNRTI, lersivirine (UK-453,061), in healthy adult subjects.
Langdon G, Davis J, Layton G, Chong CL, et al · · 2012 · cited 6× · PMID 22040521 · DOI 10.1111/j.1365-2125.2011.04136.x

Verify or expand the search:

Other recruiting trials for HIV-1

Currently open trials in the same condition.

NCT06517693 — Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 · Phase 1 · recruiting
NCT06252402 — CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS · EARLY_PHASE1 · recruiting
NCT05612178 — A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs · Phase 1 · active not recruiting
NCT00980538 — TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants · Phase 3 · active not recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · 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 NCT00824421 (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 Pfizer
Last refreshed: 9 December 2013

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/NCT00824421.

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