REMUNE^® CLINICAL TRIALS

(Last Updated : November 15, 2004)

The REMUNE^® Clinical Trials in Thailand started with Protocol 2101A, a Phase II open-label study with thirty HIV+ Thai subjects enrolled in Ramathibodi Hospital in February 1996. All subjects received four doses of HIV-1 Immunogen (REMUNE^®) once a month from March 1996 to July 1996. Resulting data was published in the Journal Vaccine. The protocol 2101A continued with a 1-year extension study (P2101A/F1 Extension) and similarly published in the Journal AIDS. Later in August 1997, Protocol 2101B, a double-blind, randomized, placebo controlled study, enrolled 297 HIV+ Thai subjects in a 40-week period. All P2101B protocols from Day 1 up to Week 232 were officially approved by the Technical Subcommittee on HIV/AIDS Vaccine Development, under the National AIDS Committee, and the Ethical Review Committee of Research in Human Subjects, MOPH, Thailand.

The results of the study were published in the Journal Clinical and Diagnostic Laboratory Immunology (CDLI). Protocol 2101B's 40-week duration was extended up to 132 weeks (P2101B Two Years Extension Study) and another extension up to 232 weeks (P2101B additional 3-4 Years Extension Study). P2101B, 132 weeks (2 years) Extension Study findings were published in the Journal HIV Clinical Trials (HCT). Another study for open-label, multi-institute extended Phase II (P2101B) were examined in 223 asymptomatic HIV-1-infected Thai volunteers receiving REMUNE^® every 12 weeks over 132 weeks. Resulting data was published in HIV Medicine. Another article regarding the results of the REMUNE^® study was later on published in the Journal of HIV Therapy.

Recently, the Thailand Food and Drug Administration (Thai-FDA) accepted the Biologic License Application (BLA) of REMUNE^® submitted for Marketing Authorization Approval.

Thai-FDA appointed experts are now reviewing the common technical dossier of REMUNE^® to prove its safety and efficacy.

A. PROTOCOL 2101A (30 HIV+, 16 Weeks) Publication

Vaccine Journal 1998. Vol.16, No.2/3, 142-149

B. PROTOCOL 2101A/F1 Extension (30 HIV+, 60 Weeks) Publication

AIDS Journal 1998. Vol. 12:1521-1527

C. PROTOCOL 2101B (297 HIV+, 40 Weeks) Publication

Clinical and Diagnostic Immunology Laboratory Journal Sept. 2000; 7(5):728-733

D. PROTOCOL 2101B Extension (132 Weeks) Publication

HIV Clinical Trials Sept/Oct. 2001; 2(5): 391-398

E. PROTOCOL 2101B Extension (132 Weeks) Publication

HIV Medicine 2004; 5(5): 317-325

F. PROTOCOL 2101B Extention (132 Weeks) Publication

Journal of HIV Therapy Sep. 2004; 9(3) : 57-59

G. PROTOCOL Extended Phase II 2101B Extension Study (232 Weeks)

Title of the Study

STUDY OF THE EFFECT OF HIV-1 IMMUNOGEN (REMUNE^®) ON SAFETY and IMMUNOGENICITY IN HIV-INFECTED SUBJECTS IN THAILAND WITH CD4+ COUNTS ≥ 300

Objective

Extended Follow-up Study -Year 3-4: Open-label Dosing with REMUNE™ every 12 weeks to study the long term effect of REMUNE™ vaccine

Population

Remaining subjects from 2101B Extension Study (2 Years)

Current Status

Clinical trial ended in May 2003. As of June 2003, data collection, clarification and analysis are being undertaken.

425/129 Silom 5, Silom Road,
Bangkok 10500 Thailand
Telephone (662) 234-6390 - 91
Fax. No. (662) 636-6888
tac@trinitycorp.com

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