Trial Outcomes & Findings for HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study (NCT NCT03560258)
NCT ID: NCT03560258
Last Updated: 2022-04-26
Results Overview
Conserved elements (CEs) are regions of the HIV-1 p24Gag protein that rarely mutate. Seven such regions were considered in this study. At week 0 and at week 26, the CD4 cells and CD8 cells were tested to see whether they responded to each of these gene sequences. The number of regions which caused a CD4 or a CD8 response was counted. Then the difference was calculated: the number of CEs causing a response at week 26 minus the number of CEs causing a response at week 0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
week 0 and week 26
Results posted on
2022-04-26
Participant Flow
Participants were enrolled at 15 Clinical Research Sites (CRSs) in the United States between March 2019 and October 2019.
Participant milestones
| Measure |
Arm A: p24CE/Full-length Gag DNA
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
11
|
12
|
|
Overall Study
Received at Least 1 Dose of Treatment
|
22
|
10
|
12
|
|
Overall Study
COMPLETED
|
19
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm A: p24CE/Full-length Gag DNA
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine Study
Baseline characteristics by cohort
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=22 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=12 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
CD4 Cell Count, Continuous
|
823 cells/mm^3
STANDARD_DEVIATION 247 • n=5 Participants
|
969 cells/mm^3
STANDARD_DEVIATION 352 • n=7 Participants
|
903 cells/mm^3
STANDARD_DEVIATION 256 • n=5 Participants
|
878 cells/mm^3
STANDARD_DEVIATION 276 • n=4 Participants
|
|
Nadir CD4, Continuous
|
514 cells/mm^3
STANDARD_DEVIATION 184 • n=5 Participants
|
471 cells/mm^3
STANDARD_DEVIATION 117 • n=7 Participants
|
491 cells/mm^3
STANDARD_DEVIATION 117 • n=5 Participants
|
498 cells/mm^3
STANDARD_DEVIATION 153 • n=4 Participants
|
|
HIV-1 RNA Level: <40 copies/mL, ≥40 copies/mL
<40 copies/mL
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
HIV-1 RNA Level: <40 copies/mL, ≥40 copies/mL
≥40 copies/mL
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
HIV-1 RNA Level: <40 copies/mL, ≥40 copies/mL
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Weight, Continuous
|
86.7 kilogram
STANDARD_DEVIATION 13.4 • n=5 Participants
|
80.4 kilogram
STANDARD_DEVIATION 11.8 • n=7 Participants
|
89.7 kilogram
STANDARD_DEVIATION 15.6 • n=5 Participants
|
86.1 kilogram
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
IV Drug Use: No, Yes
No
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
IV Drug Use: No, Yes
Yes
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 0 and week 26Population: The primary comparison was based on the complete case analysis, i.e., removed records with missing data.
Conserved elements (CEs) are regions of the HIV-1 p24Gag protein that rarely mutate. Seven such regions were considered in this study. At week 0 and at week 26, the CD4 cells and CD8 cells were tested to see whether they responded to each of these gene sequences. The number of regions which caused a CD4 or a CD8 response was counted. Then the difference was calculated: the number of CEs causing a response at week 26 minus the number of CEs causing a response at week 0.
Outcome measures
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=18 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=10 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Change in the Number of Conserved Elements (CEs) With a CD4 or a CD8 T Cell Response From Week 0 to Week 26
|
0 Number of CEs
Interval -1.0 to 1.0
|
0 Number of CEs
Interval 0.0 to 1.0
|
0 Number of CEs
Interval -1.0 to 0.0
|
PRIMARY outcome
Timeframe: Measured from treatment initiation through Week 48Population: One participant randomized to Arm B did not receive study treatment and was not part of the safety analysis.
Injection site pain or tenderness of less than 48 hours duration was not considered as primary safety outcome; Grade 4 AEs and deaths at any time on study were considered as primary safety outcomes. Sites referred to the DAIDS AE Grading Table, corrected Version 2.1, July 2017, to grade AEs. The relationship to study treatment was judged by the core team, blinded to treatment arm.
Outcome measures
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=22 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=12 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Occurrence of at Least One Greater Than or Equal to Grade 3 Adverse Event (AE) That Was Possibly, Probably, or Definitely Related to Study Treatment.
yes
|
4.55 percentage of participants
Interval 0.12 to 22.84
|
0 percentage of participants
Interval 0.0 to 30.85
|
0 percentage of participants
Interval 0.0 to 26.47
|
|
Occurrence of at Least One Greater Than or Equal to Grade 3 Adverse Event (AE) That Was Possibly, Probably, or Definitely Related to Study Treatment.
no
|
95.45 percentage of participants
Interval 77.16 to 99.88
|
100 percentage of participants
Interval 69.15 to 100.0
|
100 percentage of participants
Interval 69.15 to 100.0
|
SECONDARY outcome
Timeframe: week 0 and week 26Population: The comparison was based on the complete case analysis, i.e., removed records with missing data.
Conserved elements (CEs) are regions of the HIV-1 p24Gag protein that rarely mutate. Seven such regions were considered in this study. At week 0 and at week 26, the CD4 cells were tested to see whether they responded to each of these gene sequences. The number of regions which caused a CD4 response was counted. Then the difference was calculated: the number of CEs causing a response at week 26 minus the number of CEs causing a response at week 0.
Outcome measures
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=18 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=10 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Change in the Number of CEs With a CD4 T Cell Response From Week 0 to Week 26
|
0 Number of CEs
Interval -1.0 to 1.0
|
0 Number of CEs
Interval -1.0 to 0.0
|
0 Number of CEs
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: week 0 and week 26Population: The comparison was based on the complete case analysis, i.e., removed records with missing data.
Conserved elements (CEs) are regions of the HIV-1 p24Gag protein that rarely mutate. Seven such regions were considered in this study. At week 0 and at week 26, the CD8 cells were tested to see whether they responded to each of these gene sequences. The number of regions which caused a CD8 response was counted. Then the difference was calculated: the number of CEs causing a response at week 26 minus the number of CEs causing a response at week 0.
Outcome measures
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=18 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=10 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Change in the Number of CEs With a CD8 T Cell Response From Week 0 to Week 26
|
0 Number of CEs
Interval 0.0 to 1.0
|
0 Number of CEs
Interval 0.0 to 1.0
|
0 Number of CEs
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: week 0 and week 26Population: The comparison was based on the complete case analysis, i.e., removed records with missing data.
The HIV-1 specific CD4 T-cell responses were assessed by the intracellular cytokine staining (ICS) assay from peripheral blood mononuclear cell (PBMC) specimens obtained at week 0 and week 26. The magnitude of CD4 T cell responses was the percentage of CD4 T cells expressing cytokine IFNγ+ or IL2.
Outcome measures
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=18 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=10 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Change in the Magnitude of HIV-1 Specific CD4 T Cell Responses From Week 0 to Week 26.
|
0.027 percentage of cells
Standard Deviation 0.090
|
0.0005 percentage of cells
Standard Deviation 0.044
|
0.004 percentage of cells
Standard Deviation 0.038
|
SECONDARY outcome
Timeframe: week 0 and week 26Population: The comparison was based on the complete case analysis, i.e., removed records with missing data.
The HIV-1 specific CD8 T-cell responses were assessed by the intracellular cytokine staining (ICS) assay from peripheral blood mononuclear cell (PBMC) specimens obtained at week 0 and week 26. The magnitude of CD8 T cell responses was the percentage of CD8 T cells expressing cytokine IFNγ+ or IL2.
Outcome measures
| Measure |
Arm A: p24CE/Full-length Gag DNA
n=18 Participants
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
Arm B: Full-length Gag DNA
n=10 Participants
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
Arm C: Placebo
n=10 Participants
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Change in the Magnitude of HIV-1 Specific CD8 T Cell Responses From Week 0 to Week 26.
|
0.042 percentage of cells
Standard Deviation 0.149
|
0.220 percentage of cells
Standard Deviation 0.558
|
0.045 percentage of cells
Standard Deviation 0.136
|
Adverse Events
ArmA
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
ArmB
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ArmC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ArmA
n=22 participants at risk
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
ArmB
n=10 participants at risk
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
ArmC
n=12 participants at risk
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
4.5%
1/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
Other adverse events
| Measure |
ArmA
n=22 participants at risk
Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24.
p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation
p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation
|
ArmB
n=10 participants at risk
Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24.
Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation
|
ArmC
n=12 participants at risk
Participants received placebo at Weeks 0, 4, 12, and 24.
Placebo: 1 mL placebo administered by one injection/electroporation
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
10.0%
1/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Injection site erythema
|
9.1%
2/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
20.0%
2/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
16.7%
2/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Injection site pain
|
45.5%
10/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
30.0%
3/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
33.3%
4/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Injection site rash
|
4.5%
1/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Injection site swelling
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
10.0%
1/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
25.0%
3/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Vaccination site bruising
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Vaccination site pain
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Vaccination site pruritus
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Infections and infestations
Staphylococcal abscess
|
4.5%
1/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
10.0%
1/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
10.0%
1/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
10.0%
1/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/22 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
0.00%
0/10 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
8.3%
1/12 • From treatment initiation to study completion at Week 48 or premature study discontinuation
Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place