HIV Infections
Conditions
Keywords
HIV, vaccine, lipopeptide, Tat, TUTI-16, THYMON
Brief summary
This protocol represents the third in human study of TUTI-16, and is being conducted to gather additional safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.
Detailed description
In this study, HIV-1 infected subjects on ART, with undetectable HIV-1 viral load, will be immunized with 1mg TUTI-16 or placebo in a randomized double blind fashion (prime and 3 week boost). Three weeks after the 3 week boost (week 6) ART will be stopped. HIV-1 viral load and CD4+ T-cell levels will be determined at defined intervals through 54 weeks (48 weeks Post ART discontinuation).
Interventions
BIOLOGICALTUTI-16 (1.0 mg)
Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.
OTHERPlacebo
Two subcutaneous injections of Placebo at Day 0 and Week 3.
Sponsors
Thymon, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Males and Females * Age ≥ 18 and ≤ 50 years at Screening * Body weight of 50-100 kg (inclusive) at Screening. * HIV-1 seropositive subjects on effective ART for \> 12 months (undetectable HIV plasma viremia), viral set point before ART \> 10,000. * CD4+ T-cell count ≥ 500/mm3. * No antiviral drug within 8 weeks of screening. Patients stabilized on Aciclovir and Valciclovir for more than 6 months may be enrolled. * Karnofsky performance status \> 90% at screening. * In good health as determined by medical history, a baseline physical examination, vital signs, and clinical laboratory tests. * Subject is willing and able to sign written informed consent prior to beginning study procedures. * Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
Exclusion criteria
* Females planning to become pregnant during the course of the study. * Females with a positive pregnancy test at Screening or study enrollment. * Any out-of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Principal Investigator. * Systemic infection or other vaccination within 6 weeks prior to screening. Live vaccine within 1 year of screening. * Autoimmune disease (e.g., psoriasis, rheumatoid arthritis, etc.) or inflammatory bowel disease confirmed by clinical history. * Positive at screen for HBV (by HBsAg assay) or HCV (by antibody ELISA) unless there is no active infection as judged by an elevated alanine aminotransferase (ALT) at screening. * Alanine aminotransferase (ALT) above the upper limit of normal at screening. * Hemoglobin outside of laboratory normal range at screening. * Absolute neutrophil counts outside of laboratory normal range at screening. * Platelet count outside of laboratory normal range at screening. * A history of significant drug allergy. * A general medical or psychological condition or behavior, including current substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent. * Subjects experiencing an acute Herpetic event. * Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator would make the subject unsuitable for the study or put them at additional risk. * Routine or PRN consumption of immune suppressive medications that the subject is unable or unwilling to discontinue during the study. * Inability to understand or follow study instructions. * Participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Tat Antibody Titer | 54 weeks | ELISA based chemiluminescent assay to determine the anti-Tat antibody response |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TUTI-16 (1.0 mg) Two subcutaneous injections of 1.0 mg at Day 0 and Week 3. | 16 |
| Placebo Two subcutaneous injections of placebo at Day 0 and Week 3. | 11 |
| Total | 27 |
Baseline characteristics
| Characteristic | TUTI-16 (1.0 mg) | Placebo | Total |
|---|---|---|---|
| Age, Customized Between 18 and 65 years | 45 years | 43 years | 43 years |
| Region of Enrollment United States | 16 participants | 11 participants | 27 participants |
| Sex: Female, Male Female | 12 Participants | 2 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 16 | 1 / 11 |
| serious Total, serious adverse events | 0 / 16 | 0 / 11 |
Outcome results
Primary
Anti-Tat Antibody Titer
ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Time frame: 54 weeks
Population: all subjects enrolled
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TUTI-16 (1.0 mg) | Anti-Tat Antibody Titer | 698 ng/mL |
| Placebo | Anti-Tat Antibody Titer | 4 ng/mL |