Trial Outcomes & Findings for Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial (NCT NCT01177059)
NCT ID: NCT01177059
Last Updated: 2018-12-12
Results Overview
Percentage of participants with clonal expansion of cells with a predominant OZ1 insertion site was reported. A predominant integration site was defined as an integration site which has a density of at least 50 percent (%) of the total signal detected by polymerase chain reaction (PCR), when the percentage of cells marked by vector was greater than (\>)1% of the test cell population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Approximately up to 15 years
Results posted on
2018-12-12
Participant Flow
Participants who completed original study (OTH/OZ1-INT-1 \[NCT00074997\]) were enrolled in this long term follow-up (LTFU) study. After unblinding of original study, participants in placebo group were withdrawn from LTFU study, except first participant who received Moloney murine leukemia virus based retroviral vector (LNL6) transduced CD34+ cells.
Participant milestones
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Overall Study
Received placebo in OTH/OZ1-INT-1 study
|
30
|
|
Overall Study
Withdrew consent
|
2
|
|
Overall Study
Lost to Follow-up
|
18
|
Baseline Characteristics
Long Term Follow-Up Study of Human Immunodeficiency Virus Type 1 (HIV-1) Positive Patients Who Have Received OZ1 Gene Therapy as Part of a Clinical Trial
Baseline characteristics by cohort
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
n=68 Participants
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 5.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Maori/Polynesian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 15 yearsPopulation: Per protocol (PP) population set included all participants in the safety population who received OZ1 or Moloney murine leukemia virus based retroviral vector (LNL6) transduced final cell product in the original OTH/OZ1-INT-1 study.
Percentage of participants with clonal expansion of cells with a predominant OZ1 insertion site was reported. A predominant integration site was defined as an integration site which has a density of at least 50 percent (%) of the total signal detected by polymerase chain reaction (PCR), when the percentage of cells marked by vector was greater than (\>)1% of the test cell population.
Outcome measures
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
n=37 Participants
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Percentage of Participants With Clonal Expansion of Cells With a Predominant OZ1 Insertion Site
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Approximately up to 15 yearsPopulation: Per protocol population set included all participants in the safety population who received OZ1 or LNL6 transduced final cell product in the original OTH/OZ1-INT-1 study.
Percentage of participants with insertional oncogenesis by clonal expansion of cells modified with OZ1/LNL6 were reported.
Outcome measures
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
n=37 Participants
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Percentage of Participants With Insertional Oncogenesis
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to end of study (Approximately up to 15 years)Population: PP population set included all participants in safety population who received OZ1/LNL6 transduced final cell product in original OTH/OZ1-INT-1 study. Here 'n' specifies participants analyzed for this endpoint at given time point.
OZ1 and LNL6 marking analysis were performed by quantitative deoxyribonucleic acid-polymerase chain reaction (DNA-PCR). Number of participants in each of 3 categories for gene detection: Not Detected, Detected (1, 2 and 3 of the 3 triplicates of the sample were detected respectively \[1/3 Detected, 2/3 Detected, 3/3 Detected\]) and Detected (Quantifiable) were reported for marking of gene transfer product in PBMC.
Outcome measures
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
n=37 Participants
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
6 years post-infusion: Detected (Quantifiable)
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
9 years post-infusion: 1/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
9 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2 years post-infusion: Not Detected
|
33 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2 years post-infusion: 1/3 Detected
|
4 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2.5 years post-infusion: Not Detected
|
31 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2.5 years post-infusion: 1/3 Detected
|
2 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2.5 years post-infusion: 2/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2.5 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
2.5 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3 years post-infusion: Not Detected
|
31 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3 years post-infusion: 1/3 Detected
|
3 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3 years post-infusion: 3/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3.5 years post-infusion: Not Detected
|
28 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3.5 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3.5 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3.5 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
3.5 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4 years post-infusion: Not Detected
|
28 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4 years post-infusion: 1/3 Detected
|
4 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4.5 years post-infusion: Not Detected
|
19 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4.5 years post-infusion: 1/3 Detected
|
5 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4.5 years post-infusion: 2/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4.5 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
4.5 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
5 years post-infusion: Not Detected
|
27 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
5 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
5 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
5 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
5 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
6 years post-infusion: Not Detected
|
18 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
6 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
6 years post-infusion: 2/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
6 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
7 years post-infusion: Not Detected
|
9 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
7 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
7 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
7 years post-infusion: 3/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
7 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
8 years post-infusion: Not Detected
|
9 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
8 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
8 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
8 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
8 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
9 years post-infusion: Not Detected
|
6 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
9 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
9 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
10 years post-infusion: Not Detected
|
9 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
10 years post-infusion: 1/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
10 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
10 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
10 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
11 years post-infusion: Not Detected
|
7 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
11 years post-infusion: 1/3 Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
11 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
11 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
11 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
12 years post-infusion: Not Detected
|
7 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
12 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
12 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
12 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
12 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
13 years post-infusion: Not Detected
|
3 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
13 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
13 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
13 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
13 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
14 years post-infusion: Not Detected
|
1 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
14 years post-infusion: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
14 years post-infusion: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
14 years post-infusion: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
14 years post-infusion: Detected (Quantifiable)
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
End of study: Not Detected
|
6 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
End of study: 1/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
End of study: 2/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
End of study: 3/3 Detected
|
0 Participants
|
|
Number of Participants With Quantitative Marking of Gene Transfer Product in Peripheral Blood Mononuclear Cells (PBMC) Over Time
End of study: Detected (Quantifiable)
|
0 Participants
|
Adverse Events
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
Serious events: 7 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
n=68 participants at risk
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Injury, poisoning and procedural complications
Rib Fracture
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's Sarcoma
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicle Adenoma
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Baby
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
Other adverse events
| Measure |
Anti-HIV-1 Ribozyme (OZ1) Transduced Cells
n=68 participants at risk
Participants who received an infusion of final cell product (that is, a cluster of differentiation \[CD\]34+ cells with or without gene transfer product) in the original study (OTH/OZ1-INT-1) were followed up in this study.
|
|---|---|
|
Vascular disorders
Hypertension
|
1.5%
1/68 • Approximately up to 15 years
The safety population included all participants who were enrolled in the original OTH/OZ1-INT-1 study and continued participation in the long term follow-up OZ1-HV1-202/OZ1HIV2001 study.
|
Additional Information
Executive Director Medical & Scientific
Janssen-Cilag Pty Ltd, Australia
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER