Trial Outcomes & Findings for Interferon Alpha 2b Intensification in HIV-Positive Individuals on Antiretroviral Therapy (NCT NCT01295515)
NCT ID: NCT01295515
Last Updated: 2019-04-23
Results Overview
Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects RNA.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
week 4 (post) compared to week 0 (pre)
Results posted on
2019-04-23
Participant Flow
Participant milestones
| Measure |
Interferon Treatment
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interferon Alpha 2b Intensification in HIV-Positive Individuals on Antiretroviral Therapy
Baseline characteristics by cohort
| Measure |
Interferon Treatment
n=7 Participants
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
48.85 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 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
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 4 (post) compared to week 0 (pre)Population: A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.
Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects RNA.
Outcome measures
| Measure |
Interferon Treatment
n=7 Participants
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #6 HIV RNA Pre
|
850 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #1 HIV RNA Pre
|
670 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #1 HIV RNA Post
|
180 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #2 HIV RNA Pre
|
90 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #2 HIV RNA Post
|
130 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #3 HIV RNA Pre
|
810 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #3 HIV RNA Post
|
420 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #4 HIV RNA Pre
|
450 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #4 HIV RNA Post
|
390 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #5 HIV RNA Pre
|
12 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #5 HIV RNA Post
|
51 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #6 HIV RNA Post
|
300 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #7 HIV RNA Pre
|
250 # of copies of HIV RNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Patient #7 HIV RNA Post
|
310 # of copies of HIV RNA/million cells
|
PRIMARY outcome
Timeframe: week 4 (post) compared to week 0 (pre)Population: A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.
Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects C-C chemokine receptor type 5 (CCR5) DNA.
Outcome measures
| Measure |
Interferon Treatment
n=7 Participants
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #1 HIV DNA Pre
|
1200 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #1 HIV DNA Post
|
790 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #2 HIV DNA Pre
|
150 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #2 HIV DNA Post
|
150 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #3 HIV DNA Pre
|
660 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #3 HIV DNA Post
|
500 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #4 HIV DNA Pre
|
400 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #4 HIV DNA Post
|
310 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #5 HIV DNA Pre
|
10 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #5 HIV DNA Post
|
19 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #6 HIV DNA Pre
|
520 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #6 HIV DNA Post
|
420 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #7 HIV DNA Pre
|
390 # of copies of DNA/million cells
|
|
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Patient #7 HIV DNA Post
|
460 # of copies of DNA/million cells
|
SECONDARY outcome
Timeframe: week 4 (post) and week 0 (pre)Population: A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.
The outcome measure is the fold change in the ratio of HIV RNA to HIV DNA. For the pre and post interferon time point, the level of HIV RNA is divided by the level of HIV DNA and this ratio of the HIV RNA/DNA pre and post interferon is calculated to yield the fold change in HIV RNA/DNA levels. Fold change does not have units.
Outcome measures
| Measure |
Interferon Treatment
n=7 Participants
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #1
|
0.408 fold change
|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #2
|
1.44 fold change
|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #3
|
0.684 fold change
|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #4
|
1.12 fold change
|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #5
|
2.24 fold change
|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #6
|
4.37 fold change
|
|
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Patient #7
|
1.05 fold change
|
SECONDARY outcome
Timeframe: week 4 (post) compared to week 0 (pre)Population: Median and standard deviation were calculated using multiple samples from each participant. On patient #5 there was an error with the machine when the samples were ran and they did not have any other samples to rerun it. Patient #5 will not be analyzed since there is no more samples.
The outcome measure is copies of HIV RNA per ml of plasma. HIV RNA levels are measured using a polymerase chain reaction method.
Outcome measures
| Measure |
Interferon Treatment
n=6 Participants
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #1 Pre
|
0.7 copies/ml
Standard Deviation 0.8
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #1 Post
|
3.8 copies/ml
Standard Deviation 1.9
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #2 Pre
|
0.2 copies/ml
Standard Deviation 0.4
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #2 Post
|
.02 copies/ml
Standard Deviation 0
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #3 Pre
|
3.8 copies/ml
Standard Deviation 1.9
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #3 Post
|
0.8 copies/ml
Standard Deviation 0.9
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #4 Pre
|
.02 copies/ml
Standard Deviation 0
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #4 Post
|
1.5 copies/ml
Standard Deviation 1.2
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #6 Pre
|
1.3 copies/ml
Standard Deviation 1.1
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #6 Post
|
0.36 copies/ml
Standard Deviation 0.6
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #7 Pre
|
9.1 copies/ml
Standard Deviation 3.0
|
|
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Patient #7 Post
|
8.8 copies/ml
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Date consent signed to date off study, approximately 66 months and 2 days.Here is the count of participants with serious and non-serious adverse events assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events for severity (mild/moderate/severe), expectedness (expected/unexpected), and relatedness to study drug (definitely, probably, possibly, unlikely, or unrelated).
Outcome measures
| Measure |
Interferon Treatment
n=7 Participants
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events.
|
7 Participants
|
Adverse Events
Interferon Treatment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interferon Treatment
n=7 participants at risk
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
Other adverse events
| Measure |
Interferon Treatment
n=7 participants at risk
Interferon treatment
Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Number of events 3 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 4 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
42.9%
3/7 • Number of events 7 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • Number of events 4 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Blood cholesterol increased
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Vascular disorders
Blood pressure increased
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dermatophytosis
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 3 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Number of events 4 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 7 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Hemoglobin decreased
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 7 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
2/7 • Number of events 7 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Number of events 2 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Number of events 2 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Injury, poisoning and procedural complications
Injection site erythema
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
28.6%
2/7 • Number of events 3 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Injury, poisoning and procedural complications
Injury
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
71.4%
5/7 • Number of events 12 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 2 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Neutrophil count decreased
|
71.4%
5/7 • Number of events 10 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
General disorders
Pain
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Platelet count decreased
|
28.6%
2/7 • Number of events 4 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Investigations
Prothrombin time prolonged
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
General disorders
Pyrexia
|
57.1%
4/7 • Number of events 6 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
14.3%
1/7 • Number of events 1 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
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Gastrointestinal disorders
Vomiting
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28.6%
2/7 • Number of events 2 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
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Investigations
White blood cell count decreased
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28.6%
2/7 • Number of events 2 • The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place