NCT01289106 is a Phase 3 clinical trial of Hepavax-Gene in HIV Infection, sponsored by Chiang Mai University.

Who is sponsoring NCT01289106?

NCT01289106 is sponsored by Chiang Mai University.

What drugs are being tested in NCT01289106?

Interventions in NCT01289106: Hepavax-Gene, Hepavax-Gene, Hepavax-Gene.

What condition does NCT01289106 study?

NCT01289106 studies HIV Infection.

Is NCT01289106 still recruiting?

NCT01289106 is currently status unknown. Last updated 2 February 2011.

Last reviewed 2011-02-02 · How we verify

NCT01289106

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

Open-Label, Randomized Controlled Trial Comparing Three Strategies of Hepatitis B Vaccination in HIV-1-Infected Patients With CD4 Cell Counts Above 200 permm3 and Suppressed Viral Load

Status unknown Phase 3 Last updated 2 February 2011

What this trial tests

Phase 3 trial testing Hepavax-Gene in HIV Infection in 132 participants. Status unknown.

Timeline

1 January 2011

Primary endpoint
1 October 2011

1 April 2012

Quick facts

Lead sponsor	Chiang Mai University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	132
Start date	1 January 2011
Primary completion	1 October 2011
Estimated completion	1 April 2012
Sites	1 location across Thailand

Drugs / interventions tested

Hepavax-Gene — full drug profile →
Hepavax-Gene — full drug profile →
Hepavax-Gene — full drug profile →

Conditions studied

HIV Infection — all drugs for HIV Infection →

Sponsor

Chiang Mai University

Who can join

Adults 18 to 60, any sex, with HIV 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.

Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210
Time frame: Day 210
1. To compare the seroconversion rate at day 210 of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) 2. To compare the seroconversion rate at day 210 of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients

Sponsor's own description

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.

Publications & conference data

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

Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial.
Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, et al · · 2013 · cited 40× · PMID 24265819 · DOI 10.1371/journal.pone.0080409

Verify or expand the search:

Other recruiting trials for HIV Infection

Currently open trials in the same condition.

NCT06900829 — #AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-i · NA · recruiting
NCT06908252 — MAPS PrEP Van Study · Phase 4 · recruiting
NCT07042945 — MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003) · Phase 1 · recruiting
NCT06716450 — Multiplo Tp/HIV Self-Test · NA · recruiting
NCT07086989 — Cardiovascular Risk in Children With Chronic Conditions Study · recruiting

Other Chiang Mai University trials

Trials by the same sponsor.

NCT07366775 — A Telenursing Program to Support Diabetes Self-Management · NA · active not recruiting
NCT07032610 — Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents · not yet recruiting
NCT06978621 — Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV · Phase 3 · recruiting
NCT06905041 — Preoperative Anemia Affected to Postoperative Outcomes in Liver Resection · not yet recruiting
NCT07476404 — Re-bleeding in Giant Meningioma and Intraoperative Hydroxyethyl Starch (HES) Fluid Therapy · completed

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 NCT01289106 (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 Chiang Mai University
Last refreshed: 2 February 2011

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/NCT01289106.

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