Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects (GCHT01)
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|ClinicalTrials.gov Identifier: NCT01428596|
Recruitment Status : Recruiting
First Posted : September 5, 2011
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: HIVAX Biological: saline solution||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Replication-defective HIV-1 Vaccine (HIVAX™) in HIV-1 Infected Subjects Receiving Highly Active Antiretroviral Therapy|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Arm I
Lower dose HIVAX vaccine
Vaccine 1.0 ml SQ lower dose (10^8 TU) at weeks 0, 8 and 16.
Placebo Comparator: Arm II
lower dose, placebo control
Biological: saline solution
Saline solution 1.0 ml SQ at weeks 0, 8 and 16.
Experimental: Arm III
Higher dose HIVAX vaccine
Vaccine 1.0 ml SQ higher dose (10^9 TU) at weeks 0, 8 and 16.
- • To evaluate the safety of a replication-defective HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects on highly active antiretroviral therapy. [ Time Frame: 48 weeks ]Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations.
- • 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. [ Time Frame: 48 weeks ]Magnitude of IFN-γ & IL-2 producing CD4+ and CD8+ T cells to pooled gag and env HIV peptides at 4 weeks post vaccinations.
- To explore the potential effectiveness of a replication-defective HIV-1 vaccine as a therapeutic vaccine [ Time Frame: 48 weeks ]
- Changes in CD4+ and CD8+ T-cell counts between the vaccine and placebo groups.
- Changes in functional and phenotypic specific HIV gag and env induced T cell responses including in CD8 and CD4 T subsets.
- HIV-1 RNA viral set point following antiretroviral treatment interruption, defined as the average of HIV-1 RNA values during the last two study visits of the antiretroviral treatment interruption.
- Time to virologic rebound (HIV-1 RNA ≥ 5,000 copies/ml).
- Breadth of HV-1 specific CD8+ T cell responses as determined by IFN-γ ELISPOT using overlapping HIV peptides for gag and env.
- 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. [ Time Frame: 16 weeks ]Treatment interruption: the number and percentage: 1)meet HIV-1 RNA (>2.0 fold above nadir and >5,000 copies/mL on two consecutive measurements verified at least one week apart) and CD4+ criteria (<400 cell/mm3 or 50% decreases from baseline in CD4 cell count on two consecutive measurements verified at least one week apart) to re-institute treatment before 12 wks; 2)genotypic resistance in re-emergent virus. Treatment resumption: the number and percentage: 1)meet criteria for virologic failure; 2)genotypic resistance in patients with virologic failure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428596
|Contact: Margaret A. Fischl, MDfirstname.lastname@example.org|
|United States, Florida|
|University of Miami School of Medicine, AIDS Clinical Research unit||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Margaret Fischl 305-243-3838|
|Principal Investigator: Margaret A. Fischl, MD|
|Study Director:||Margaret Fischl, MD||University of Miami|