Trial Outcomes & Findings for Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART) (NCT NCT03212989)
NCT ID: NCT03212989
Last Updated: 2023-05-12
Results Overview
Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse events. Safety data will be routinely collected throughout the duration of the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Up to end of study (weeks 16 through 45)
Results posted on
2023-05-12
Participant Flow
As per study protocol, screening and enrollment occur in Step 1. After establishment of the baseline safety (Visit 1) parameters and qualifying for the study per the Inclusion and Exclusion Criteria, the participant is enrolled (Visit 2) and completes the baseline leukapheresis.
Participant milestones
| Measure |
Vorinostat (VOR) + HIV-specific T-cell (HXTC) Arm
This is an open label single arm study. All eligible participants receive the following interventions:
* Step 2 - Single dose of Vorinostat (VOR) 400 mg PO
* Step 4 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 2 HXTC infusions
* Step 5 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 3 HXTC infusions
Vorinostat and HXTC: In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Completed Baseline Leukapheresis
|
17
|
|
Overall Study
First Intervention Series VOR/HXTC Infusion
|
9
|
|
Overall Study
Second Intervention Series VOR/HXTC Infusion
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Vorinostat (VOR) + HIV-specific T-cell (HXTC) Arm
This is an open label single arm study. All eligible participants receive the following interventions:
* Step 2 - Single dose of Vorinostat (VOR) 400 mg PO
* Step 4 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 2 HXTC infusions
* Step 5 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 3 HXTC infusions
Vorinostat and HXTC: In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
|
|---|---|
|
Overall Study
Physician Decision
|
8
|
Baseline Characteristics
Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)
Baseline characteristics by cohort
| Measure |
Vorinostat (VOR) + HIV-specific T Cell (HXTC) Arm
n=9 Participants
This is an open label single arm study. All eligible participants receive the following interventions:
* Step 2 - Single dose of Vorinostat (VOR) 400 mg PO
* Step 4 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 2 HXTC infusions
* Step 5 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 3 HXTC infusions
Vorinostat and HXTC: In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
|
|---|---|
|
Age, Continuous
|
52 Year
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to end of study (weeks 16 through 45)Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse events. Safety data will be routinely collected throughout the duration of the study.
Outcome measures
| Measure |
VOR + HXTC Arm
n=9 Participants
This is an open label single arm study. All eligible participants receive the following interventions:
* Step 2 - Single dose of Vorinostat (VOR) 400 mg PO
* Step 4 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 2 HXTC infusions
* Step 5 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 3 HXTC infusions
Vorinostat and HXTC: In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
|
|---|---|
|
Number of Participants w/ at Least One ≥ Grade 3 Adverse Event That is Possibly or Definitely Related to Vorinostat (VOR) or HIV-specific T Cell (HXTC)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to end of study (weeks 16 through 45)The change in ex vivo HIV-specific immune response from baseline was measured by interferon-gamma (IFN-γ) ELISpot throughout the study. Change in the frequency of latent HIV infection from baseline to end of study was measured using a quantitative viral outgrowth assay (QVOA). Participants that exhibited any significant changes in both of these measures were considered to have experienced a positive result.
Outcome measures
| Measure |
VOR + HXTC Arm
n=9 Participants
This is an open label single arm study. All eligible participants receive the following interventions:
* Step 2 - Single dose of Vorinostat (VOR) 400 mg PO
* Step 4 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 2 HXTC infusions
* Step 5 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 3 HXTC infusions
Vorinostat and HXTC: In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
|
|---|---|
|
Number of Participants Demonstrating an HIV-specific Immune Response to the Combination of Vorinostat (VOR) and HIV-specific T Cells (HXTC) Therapy as Well as a Change in the Frequency of Latent HIV Infection
|
0 Participants
|
Adverse Events
Vorinostat (VOR) + HIV-specific T-cell (HXTC) Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vorinostat (VOR) + HIV-specific T-cell (HXTC) Arm
n=9 participants at risk
This is an open label single arm study. All eligible participants receive the following interventions:
* Step 2 - Single dose of Vorinostat (VOR) 400 mg PO
* Step 4 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 2 HXTC infusions
* Step 5 - Vorinostat (VOR) 400 mg PO every 72 hrs x 10 doses and 3 HXTC infusions
Vorinostat and HXTC: In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
|
|---|---|
|
Cardiac disorders
Cardiac flutter
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Eye disorders
Diplopia
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Gastrointestinal disorders
Anorectal disorder
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 3 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 10 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
General disorders
Fatigue
|
44.4%
4/9 • Number of events 13 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
General disorders
Feeling hot
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
General disorders
Infusion site pain
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
General disorders
Edema peripheral
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Infections and infestations
Ear infection
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Infections and infestations
Folliculitis
|
11.1%
1/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Infections and infestations
Oral candidiasis
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Infections and infestations
Syphilis
|
22.2%
2/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
3/9 • Number of events 3 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Citrate toxicity
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
22.2%
2/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Post procedural erythema
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Infections and infestations
Procedural dizziness
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
77.8%
7/9 • Number of events 16 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
1/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Sunburn
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
22.2%
2/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Injury, poisoning and procedural complications
Vascular access site rupture
|
22.2%
2/9 • Number of events 4 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood cholesterol increased
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood creatinine increased
|
22.2%
2/9 • Number of events 3 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood glucose decreased
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood glucose increased
|
77.8%
7/9 • Number of events 9 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood magnesium decreased
|
11.1%
1/9 • Number of events 3 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood pressure increased
|
77.8%
7/9 • Number of events 32 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Blood sodium increased
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Breath sounds abnormal
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Carbon dioxide decreased
|
55.6%
5/9 • Number of events 9 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Glomerular filtration rate decreased
|
33.3%
3/9 • Number of events 7 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Lipase increased
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Lymph node palpable
|
11.1%
1/9 • Number of events 4 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Protein urine present
|
22.2%
2/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Investigations
Weight decreased
|
11.1%
1/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 5 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Nervous system disorders
Sciatica
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 2 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Skin and subcutaneous tissue disorders
Papule
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Vascular disorders
Essential hypertension
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
|
Vascular disorders
Thrombophlebitis
|
11.1%
1/9 • Number of events 1 • The Adverse Event (AE) reporting period for each participant began when the participant signed the consent and continued through the 30 days following the End of Study (EOS) visit. Prior to study product administration, any AE that occured was collected as concurrent medical history (pre-existing condition) and not as an AE, unless it was due to a protocol-related procedure (e.g., leukapheresis or large blood collection).
After study entry, any new diagnosis or illnesses that developed, grade ≥3 signs and symptoms, signs and symptoms that were related to Vorinostat (VOR) or HIV-specific T cell (HXTC) therapy, and all signs and symptoms that lead to a change in treatment, regardless of grade were recorded. Systematic assessments included routine clinical examination findings, laboratory, and post-infusion monitoring.
|
Additional Information
Cynthia Gay, MD, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-6712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place