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Cancer Vaccine

Arm I for Human Immunodeficiency Virus Infection (GCHT01 Trial)

Phase 1
Waitlist Available
Research Sponsored by GeneCure Biotechnologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

GCHT01 Trial Summary

This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.

GCHT01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
• To evaluate the potential immunogenicity of a replication-defective HIV-1 vaccine (HIVAX™) as determined by IFN-γ and IL-2 ELISPOT to pooled gag and env HIV peptides.
• To evaluate the safety of a replication-defective HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects on highly active antiretroviral therapy.
Secondary outcome measures
To explore the potential effectiveness of a replication-defective HIV-1 vaccine as a therapeutic vaccine
To monitor the impact of antiretroviral treatment interruption on viral resistance among subjects with virologic rebound (HIV-1 RNA ≥5,000 copies/ml) following resumption of antiretroviral treatment.

GCHT01 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IIIExperimental Treatment1 Intervention
Higher dose HIVAX vaccine
Group II: Arm IExperimental Treatment1 Intervention
Lower dose HIVAX vaccine
Group III: Arm IIPlacebo Group1 Intervention
lower dose, placebo control

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Who is running the clinical trial?

GeneCure BiotechnologiesLead Sponsor
2 Previous Clinical Trials
62 Total Patients Enrolled
Margaret Fischl, MDStudy DirectorUniversity of Miami
2 Previous Clinical Trials
242 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
VaccineJournal
A Therapeutic HIV-1 Vaccine Enhances Anti-hiv-1 Immune Responses in Patients Under Highly Active Antiretroviral Therapy
Tung, Frank Y., Jack K. Tung, Suresh Pallikkuth, Savita Pahwa, and Margaret A. Fischl. 2016. “A Therapeutic HIV-1 Vaccine Enhances Anti-hiv-1 Immune Responses in Patients Under Highly Active Antiretroviral Therapy”. Vaccine. Elsevier BV. doi:10.1016/j.vaccine.2016.03.021.
clinicaltrials.govStudy
Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects
2010. "Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01428596.
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~2 spots leftby Apr 2025
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