NCT01546818 is a Phase 1 clinical trial of SAV001-H in HIV Infections, sponsored by Sumagen.

Who is sponsoring NCT01546818?

NCT01546818 is sponsored by Sumagen.

What drugs are being tested in NCT01546818?

Interventions in NCT01546818: SAV001-H.

What condition does NCT01546818 study?

NCT01546818 studies HIV Infections.

Is NCT01546818 still recruiting?

NCT01546818 is currently completed. Last updated 5 September 2013.

Last reviewed 2013-09-05 · How we verify

NCT01546818

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

A Phase I, Randomized, Observer-blinded, Placebo-controlled Clinical Study to Assess the Safety, Tolerability, and Immune Response of Killed-Whole HIV-1 Vaccine (SAV001-H) Administered Intramuscularly to Chronic HIV-1 Infected Patients Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)

Completed Phase 1 Last updated 5 September 2013

What this trial tests

Phase 1 trial testing SAV001-H in HIV Infections in 33 participants. Completed in 1 September 2013.

Timeline

1 March 2012

Primary endpoint
1 March 2013

1 September 2013

Quick facts

Lead sponsor	Sumagen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	prevention
Enrollment	33
Start date	1 March 2012
Primary completion	1 March 2013
Estimated completion	1 September 2013
Sites	1 location across United States

Drugs / interventions tested

SAV001-H — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Sumagen — full company profile →

Who can join

Adults 18 to 50, 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.

Occurrence of at least one Grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events possibly or definitely related to study treatment
Time frame: 12 months

Sponsor's own description

The purpose of this study is to examine the safety, tolerability, and immune response to killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected individuals.

Publications & conference data

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

Application of radiation technology in vaccines development.
Seo HS. · · 2015 · cited 45× · PMID 26273573 · DOI 10.7774/cevr.2015.4.2.145
Lessons learned from HIV vaccine clinical efficacy trials.
Day TA, Kublin JG. · · 2013 · cited 26× · PMID 24033299 · DOI 10.2174/1570162x113116660051
First Phase I human clinical trial of a killed whole-HIV-1 vaccine: demonstration of its safety and enhancement of anti-HIV antibody responses.
Choi E, Michalski CJ, Choo SH, Kim GN, et al · · 2016 · cited 19× · PMID 27894306 · DOI 10.1186/s12977-016-0317-2
Enhancing broadly neutralising antibody suppression of HIV by immune modulation and vaccination.
Nel C, Frater J. · · 2024 · cited 4× · PMID 39575236 · DOI 10.3389/fimmu.2024.1478703

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

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 NCT01546818 (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 Sumagen
Last refreshed: 5 September 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/NCT01546818.

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