REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study (RAISE)

Immune Response BioPharma

Status and phase: Unknown; Phase 3

Conditions: HIV

Treatments: Biological: IR103

Study type: Interventional

Funder types: Industry

Identifiers

NCT02366026

IR103-007

Details and patient eligibility

About

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity.

Full description

This is a 500 subject Multi Center double-blind randomized, Safety & Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen & Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection & to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.

Enrollment: 500 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
• Are at least 16 years old (consent of parent or guardian required if under 18 years).

Exclusion criteria

• Healthy Subjects
• Currently abuse alcohol or drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups, including a placebo group

IR103 REMUNE + AMPLIVAX 1.0

Experimental group

Description:

IR103 Vaccine contain the same active component as REMUNE® (Inactivated HIV-1 Antigen Drug Substance at 10 μg/mL p24 dose), and have one dose of Amplivax™ (HYB2055) Adjuvant (1.0 mg) added before emulsification in Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).

Treatment:

Biological: IR103

AMPLIVAX 1.0 + IFA

Placebo Comparator group

Description:

AMPLIVAX 1.0 mg Amplivax™ (HYB2055) Adjuvant (1.0 mg) + IFA Incomplete Freund's Adjuvant (the same adjuvant and in the same ratio that is used in REMUNE).

Treatment:

Biological: IR103