NCT01008813 is a Phase 2 clinical trial of adjuvanted A(H1N1)v influenza vaccine in HIV Infections, sponsored by French National Agency for Research on AIDS and Viral Hepatitis.

Who is sponsoring NCT01008813?

NCT01008813 is sponsored by French National Agency for Research on AIDS and Viral Hepatitis.

What drugs are being tested in NCT01008813?

Interventions in NCT01008813: adjuvanted A(H1N1)v influenza vaccine, non-adjuvanted A(H1N1)v influenza vaccine.

What condition does NCT01008813 study?

NCT01008813 studies HIV Infections.

Is NCT01008813 still recruiting?

NCT01008813 is currently completed. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT01008813

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

A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

Completed Phase 2 Last updated 2 April 2026

What this trial tests

Phase 2 trial testing adjuvanted A(H1N1)v influenza vaccine in HIV Infections in 306 participants. Completed in 1 December 2010.

Timeline

1 October 2009

Primary endpoint
1 February 2010

1 December 2010

Quick facts

Lead sponsor	French National Agency for Research on AIDS and Viral Hepatitis
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	306
Start date	1 October 2009
Primary completion	1 February 2010
Estimated completion	1 December 2010
Sites	6 locations across France

Drugs / interventions tested

adjuvanted A(H1N1)v influenza vaccine — full drug profile →
non-adjuvanted A(H1N1)v influenza vaccine — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Who can join

18 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.

To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections.
Time frame: Day 42

Sponsor's own description

A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

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 French National Agency for Research on AIDS and Viral Hepatitis trials

Trials by the same sponsor.

NCT03671291 — Missed Opportunities to Pre-exposure Prophylaxis for HIV Infection on Person Newly Diagnosed With HIV · NA · completed
NCT04468724 — MAKASI Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Paris Greater Area · NA · unknown
NCT03459768 — Cohort Study on People Who Inject Drugs in Senegal · unknown
NCT00927290 — Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance · Phase 3 · terminated
NCT00823342 — ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus · Phase 3 · terminated

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 NCT01008813 (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 French National Agency for Research on AIDS and Viral Hepatitis
Last refreshed: 2 April 2026

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/NCT01008813.

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