REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2017 |
| End Date: | June 2019 |
| Contact: | Richard Bartholomew, PhD. |
| Email: | RichardmBartholomew@gmail.com |
| Phone: | 858-414-4664 |
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.
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.
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.
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.
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.
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