NCT00659789 is a Phase 2 clinical trial of Vacc-4x in HIV I Infection, sponsored by Bionor Immuno AS.

Who is sponsoring NCT00659789?

NCT00659789 is sponsored by Bionor Immuno AS.

What drugs are being tested in NCT00659789?

Interventions in NCT00659789: Vacc-4x, Sterile water.

What condition does NCT00659789 study?

NCT00659789 studies HIV I Infection.

Is NCT00659789 still recruiting?

NCT00659789 is currently completed. Last updated 5 January 2017.

Are results published for NCT00659789?

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

Last reviewed 2017-01-05 · How we verify

NCT00659789

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

A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART

Completed Phase 2 Results posted Last updated 5 January 2017

What this trial tests

Phase 2 trial testing Vacc-4x in HIV I Infection in 137 participants. Completed in 1 June 2011.

Timeline

1 August 2008

Primary endpoint
1 June 2010

1 June 2011

Quick facts

Lead sponsor	Bionor Immuno AS
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	137
Start date	1 August 2008
Primary completion	1 June 2010
Estimated completion	1 June 2011
Sites	18 locations across United States, Germany, Italy, Spain, United Kingdom

Drugs / interventions tested

Vacc-4x — full drug profile →
Sterile water (Sterile Water For Injection) — full drug profile →

Conditions studied

HIV I Infection — all drugs for HIV I Infection →

Sponsor

Bionor Immuno AS — full company profile →

Who can join

Adults 18 to 55, any sex, with HIV I Infection. 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.

Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
Time frame: From Week 28 to Week 52

Sponsor's own description

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure. ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Publications & conference data

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

Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial.
Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, et al · · 2014 · cited 83× · PMID 24525316 · DOI 10.1016/s1473-3099(13)70343-8
Cell-Mediated Immune Predictors of Vaccine Effect on Viral Load and CD4 Count in a Phase 2 Therapeutic HIV-1 Vaccine Clinical Trial.
Huang Y, Pantaleo G, Tapia G, Sanchez B, et al · · 2017 · cited 11× · PMID 28970080 · DOI 10.1016/j.ebiom.2017.09.028
Conserved multiepitope vaccine constructs: A potent HIV-1 therapeutic vaccine in clinical trials.
Akbari E, Seyedinkhorasani M, Bolhassani A. · · 2023 · cited 7× · PMID 37156468 · DOI 10.1016/j.bjid.2023.102774
Quality of T-cell responses versus reduction in viral load: results from an exploratory phase II clinical study of Vacc-4x, a therapeutic HIV vaccine
Ellefsen-Lavoie K, Rockstroh J, Pollard R, Pantaleo G, et al · · 2012 · DOI 10.1186/1742-4690-9-s2-o66

Verify or expand the search:

Other recruiting trials for HIV I Infection

Currently open trials in the same condition.

NCT06799338 — Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France · recruiting
NCT06834113 — Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal o · NA · recruiting
NCT07202936 — Cervical Pre-cancer Treatment Failure Among Women Living With HIV in Zimbabwe · recruiting
NCT05947890 — Evaluating the Safety and Immunogenicity of MTBVAC · Phase 2 · recruiting
NCT05110963 — Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments · NA · active not 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 NCT00659789 (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 Bionor Immuno AS
Last refreshed: 5 January 2017

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/NCT00659789.

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