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REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

NCT02291809 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-02-23

No results posted yet for this study

Summary

The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ \& CD8+ T cell counts along with increased HIV immunity.

Conditions

Interventions

BIOLOGICAL

REMUNE

Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine

Sponsors & Collaborators

  • Immune Response BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard M Bartholomew, PhD · Immune Response BioPharma, Inc. Chief R&D Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02291809 on ClinicalTrials.gov