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This protocol represents the first in human study of TUTI-16, and is being conducted to establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously administered TUTI-16. Activity of TUTI-16 will also be determined in minimizing HIV-1 viral loads and sustaining CD4+ T-cell levels.
HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities can be blocked in vitro and in vivo by anti-Tat antibodies.
The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| TUTI-16 0.03 mg | Experimental | Subcutaneous injection on Day 0, Day 28, and Day 84 |
|
| TUTI-16 0.1 mg | Experimental | Subcutaneous injection on Day 0, Day 28, and Day 84 |
|
| TUTI-16 0.6 mg | Experimental | Subcutaneous injection on Day 0, Day 28, and Day 84 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Subcutaneous injection on Day 0, Day 28, and Day 84 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Viral Load | Change in HIV viral load from baseline | baseline and 20 weeks |
| CD4+ T-cell Count | Change in CD4+ T-cell count from baseline | baseline and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Anti-Tat Antibodies | Determination of change in anti-Tat antibody level | baseline and 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus A Conant, MD | Conant Medical Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Conant Medical Clinical Research | San Francisco | California | 94114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22336878 | Derived | Goldstein G, Chicca JJ. Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naive and antiretroviral-controlled HIV-1 infected subjects plus healthy uninfected subjects. Hum Vaccin Immunother. 2012 Apr;8(4):479-85. doi: 10.4161/hv.19184. Epub 2012 Feb 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (0.03mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| FG001 | Group 2 (0.1mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| FG002 | Group 3 (0.6mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| FG003 | Placebo | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (0.03mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| BG001 | Group 2 (0.1mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HIV Viral Load | Change in HIV viral load from baseline | Posted | Log Mean | Standard Error | HIV RNA copies/mL | baseline and 20 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (0.03mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gideon Goldstein, MD, PhD | Thymon LLC | (973) 467-9558 | gidgold@gmail.com |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| TUTI-16 (0.03mg) |
| Biological |
Subcutaneous injection on Day 0, Day 28, and Day 84 |
|
| TUTI-16 (0.1mg) | Biological | Subcutaneous injection on Day 0, Day 28, and Day 84 |
|
| TUTI-16 (0.6mg) | Biological | Subcutaneous injection on Day 0, Day 28, and Day 84 |
|
| Adverse Event |
|
| BG002 | Group 3 (0.6mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| BG003 | Placebo | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Placebo | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 |
|
|
|
| Secondary | Determination of Anti-Tat Antibodies | Determination of change in anti-Tat antibody level | Posted | Median | Full Range | ng/mL | baseline and 16 weeks |
|
|
|
| Primary | CD4+ T-cell Count | Change in CD4+ T-cell count from baseline | Posted | Log Mean | Standard Error | cells/mm3 | baseline and 20 weeks |
|
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Group 2 (0.1mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 | 0 | 7 | 5 | 7 |
| EG002 | Group 3 (0.6mg TUTI-16) | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 | 0 | 6 | 5 | 6 |
| EG003 | Placebo | Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84 | 0 | 5 | 4 | 5 |
| Injection Site Reaction | General disorders | MedDRA | Systematic Assessment | Injection site tenderness, irritation, erythema, pain, induration, swelling |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment | nausea, vomitting, diarrhea, abdominal pain upper |
|
| muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | fatigue, myalgia, muscular weakness, arthralgia, |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |