Loading clinical trials...

COMPLETEDPHASE1

A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2/JS7 DNA and MVA/HIV62B in HIV-infected Adults With Suppressed Viremia Who Started ART Within 18 Months of a Negative HIV Antibody Test

NCT01378156•GeoVax, Inc.

View on ClinicalTrials.gov

Summary

GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.

Detailed Description

GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen at weeks 1 and 9 (JS7 DNA vaccine) and weeks 17 and 25 (MVA62B). Both vaccines express Gag, Pol, and Env. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18-50 yrs.
•ART started within 18 mo. of last documented negative HIV Ab test, or within 13 mo. of last negative detuned HIV-1 Ab assay, or within 18 mo. of evolution of Western blot from indeterminate to positive in the presence of a positive Ab test
•No changes to ART treatment within 4 wks. of study entry
•Documentation of level of plasma HIV-1 RNA and CD4+ counts prior to ART
•On stable suppressive ART \[HIV-1 RNA \< 50 copies/mL (PCR) or \< 75 copies/mL (bDNA) for at least 6 mo. prior to starting vaccination\]
•No history of virologic failure
•CD4+ \> 500 cells/µL
•Nadir CD4+ \> 350 cells/µL unless measured in the setting of acute infection
•Laboratory values:
•* Hemoglobin ≥ 10g/dL (male) or 9g/dL (women)
+18 more criteria

Exclusion Criteria

•Known infection with HIV-1 subtype other than Clade B
•Chemotherapy for active malignancy in the past 12 mo.
•Prior vaccinations with any HIV-1 vaccine
•Prior vaccination against smallpox within the last 15 yrs.
•History of or known cardiac disease
•History of myositis
•Diagnosis of HIV-associated nephropathy
•Evidence of active HBV or HCV infection
•Framingham Global Risk Assessment Score consistent with high short-term (10 yr.) cardiac risk
•Receipt of immunomodulatory agents, systemic corticosteroids (including nonprescription street steroids), gamma globulin, or investigational agents (other than H1N1 influenza vaccine) within 6 mo. of screening
+9 more criteria

Locations (3)

The University of Alabama at Birmingham Alabama Vaccine Research Clinic

Birmingham, Alabama, United States

AIDS Research Alliance

Los Angeles, California, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

November 14, 2017

Enrollment

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

JS7 plasmid DNA and MVA62B vaccine

BIOLOGICAL

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

View study

COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

HIV-1 Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)

Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients