HIV
Conditions
Keywords
HIV
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALIR103
REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
Sponsors
Immune Response BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 | 52 Weeks | The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary objective is to evaluate & compare changes in WBC White Blood Cell counts between the treatment groups | 52 Weeks | The secondary objective is to evaluate & compare changes in WBC White Blood Cell Counts between the treatment groups at Week 52 |
| The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups | 52 Weeks | The secondary objective is to evaluate & compare changes in CD4+ & CD8+ T cell counts between the treatment groups at Week 52 |
Countries
United States
Contacts
Primary ContactRichard Bartholomew, PhD.
Outcome results
None listed