NCT00337701 is a Phase 4 clinical trial of enfuvirtide [Fuzeon] in HIV Infections, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT00337701?

NCT00337701 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00337701?

Interventions in NCT00337701: enfuvirtide [Fuzeon], enfuvirtide [Fuzeon].

What condition does NCT00337701 study?

NCT00337701 studies HIV Infections.

Is NCT00337701 still recruiting?

NCT00337701 is currently completed. Last updated 2 November 2015.

Last reviewed 2015-11-02 · How we verify

NCT00337701

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

Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection

Completed Phase 4 Last updated 2 November 2015

What this trial tests

Phase 4 trial testing enfuvirtide [Fuzeon] in HIV Infections in 326 participants. Completed in 1 January 2007.

Timeline

1 June 2006

Primary endpoint
1 January 2007

1 January 2007

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	326
Start date	1 June 2006
Primary completion	1 January 2007
Estimated completion	1 January 2007
Sites	44 locations across United States, Puerto Rico

Drugs / interventions tested

enfuvirtide [Fuzeon] — full drug profile →
enfuvirtide [Fuzeon] — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

16 and older, any sex, with HIV Infections. 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.

Composite endpoint (pain, induration, nodules/cysts)
Time frame: Throughout study

Sponsor's own description

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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 Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · 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 NCT00337701 (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 Hoffmann-La Roche
Last refreshed: 2 November 2015

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/NCT00337701.

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