Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects (GCHT01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|