Trial · NCT02121756
Dipyridamole for Immune Activation in HIV
NCT02121756, Phase 1, Phase 2, Completed, Sharon Riddler; results first posted 2019-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dipyridamole for Immune Activation in HIV. Trials, record NCT02121756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02121756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dipyridamole for Immune Activation in HIV
- NCT number
- NCT02121756
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Sharon Riddler
- Conditions
- HIV Infection
- Interventions
- Dipyridamole, Placebo, then Dipyridamole
- First posted
- 2014-04-23
- Last updated
- 2019-04-11
- Results first posted
- 2019-04-11
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 | Baseline to week 12 | Change in plasma levels of sCD14 from baseline to week 12 |
| Primary | Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12 | baseline to week 12 | Change in Plasma levels of sCD163 from baseline to week 12 |
| Primary | Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12 | baseline to week 12 | Change in Plasma levels of IL-6 from baseline to week 12 |
| Secondary | Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | Baseline to week 12 | To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo. |
| Secondary | Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations | First 12 weeks of dipyridamole treatment | Grade 2 or higher adverse events and treatment discontinuations |
| Secondary | Immune System Activation Assessed as the Change in the Proportion of Cycling CD4+ T Cells as Measured by Ki-67 Expression at Baseline and After Treatment With Dipyridamole | Baseline to week 12 | To assess whether Dipyridamole reduces the proportion of cycling CD4+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole. |
| Secondary | Immune System Activation as Measured by the Proportion of CD4+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | Baseline to week 12 | To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing HLA-DR and CD38 after 12 weeks of DP treatment to placebo. |
| Secondary | Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | Baseline to week 12 | To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing HLA-DR and CD38 after 12 weeks of Dipyridamole treatment to placebo. |
| Secondary | Immune System Activation Assessed by the Proportion of CD4+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment to Placebo | Baseline to week 12 | To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo. |
| Secondary | Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells | Baseline to week 12 | To assess whether Dipyridamole reduces the proportion of cycling CD8+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 | Baseline to week 12 | 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis. | pg/ml | MEDIAN |
| PRIMARY | Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12 | baseline to week 12 | 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis. | ng/ml | MEDIAN |
| PRIMARY | Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12 | baseline to week 12 | 35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis. | pg/ml | MEDIAN |
| SECONDARY | Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | Baseline to week 12 | Per protocol, participants randomized to placebo were crossed over to DP after week 12. | proportion of CD8+ T cells | MEDIAN |
| SECONDARY | Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations | First 12 weeks of dipyridamole treatment | All enrolled participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immune System Activation Assessed as the Change in the Proportion of Cycling CD4+ T Cells as Measured by Ki-67 Expression at Baseline and After Treatment With Dipyridamole | Baseline to week 12 | Per protocol, participants randomized to placebo were crossed over to DP after week 12. | proportion of cycling CD4+ T Cells | MEDIAN |
| SECONDARY | Immune System Activation as Measured by the Proportion of CD4+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | Baseline to week 12 | Per protocol, participants randomized to placebo were crossed over to DP after week 12. | proportion of CD4+ T cells | MEDIAN |
| SECONDARY | Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | Baseline to week 12 | Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12. | proportion of CD8+ T cells | MEDIAN |
| SECONDARY | Immune System Activation Assessed by the Proportion of CD4+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment to Placebo | Baseline to week 12 | Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12. | proportion of CD4+ T cells | MEDIAN |
| SECONDARY | Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells | Baseline to week 12 | Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12. | proportion of cycling CD8+ T Cells | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 | ARM A: Dipyridamole for 24 Weeks | 244500.00 | Inter-Quartile Range -318792.00 to 479000.00 | pg/ml | |
| Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | -58250.00 | Inter-Quartile Range -572567.50 to 287500.00 | pg/ml | |
| Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12 | ARM A: Dipyridamole for 24 Weeks | -6.19 | Inter-Quartile Range -78.04 to 25.93 | ng/ml | |
| Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12 | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | 5.42 | Inter-Quartile Range -38.33 to 88.33 | ng/ml | |
| Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12 | ARM A: Dipyridamole for 24 Weeks | -0.02 | Inter-Quartile Range -0.36 to 0.86 | pg/ml | |
| Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12 | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | -0.07 | Inter-Quartile Range -0.59 to 0.88 | pg/ml | |
| Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | ARM A: Dipyridamole for 24 Weeks | -0.05 | Inter-Quartile Range -0.15 to 0.00 | proportion of CD8+ T cells | |
| Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | 0.00 | Inter-Quartile Range -0.05 to 0.05 | proportion of CD8+ T cells | |
| Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations | ARM A: Dipyridamole for 24 Weeks | Grade 2 adverse events | 12 | Participants | |
| Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | Grade 2 adverse events | 10 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARM A: Dipyridamole for 24 Weeks | 21 | |
| Overall Study | STARTED | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | 19 | |
| Overall Study | COMPLETED | ARM A: Dipyridamole for 24 Weeks | 15 | |
| Overall Study | COMPLETED | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | 17 | |
| Overall Study | NOT COMPLETED | ARM A: Dipyridamole for 24 Weeks | 6 | |
| Overall Study | NOT COMPLETED | ARM B: Placebo for 12 Weeks Then Dipyridamole for 12 Weeks | 2 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | gastrointestinal | Gastrointestinal disorders | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 13 | 21 | 49 |
| other | gastrointestinal | Gastrointestinal disorders | ARM B: Placebo for 12 Weeks From Baseline to Week 12 | 8 | 19 | 16 |
| other | gastrointestinal | Gastrointestinal disorders | ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 | 5 | 19 | 18 |
| other | Neurologic | Nervous system disorders | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 13 | 21 | 28 |
| other | Neurologic | Nervous system disorders | ARM B: Placebo for 12 Weeks From Baseline to Week 12 | 5 | 19 | 6 |
| other | Neurologic | Nervous system disorders | ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 | 6 | 19 | 11 |
| other | musculoskeletal | Musculoskeletal and connective tissue disorders | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 8 | 21 | 13 |
| other | musculoskeletal | Musculoskeletal and connective tissue disorders | ARM B: Placebo for 12 Weeks From Baseline to Week 12 | 2 | 19 | 3 |
| other | musculoskeletal | Musculoskeletal and connective tissue disorders | ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 | 4 | 19 | 4 |
| other | cardiovascular | Cardiac disorders | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 6 | 21 | 12 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 0 | 21 |
| Total, all-cause mortality | ARM B: Placebo for 12 Weeks From Baseline to Week 12 | 0 | 19 |
| Total, all-cause mortality | ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 | 0 | 19 |
| Total, other adverse events | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 20 | 21 |
| Total, other adverse events | ARM B: Placebo for 12 Weeks From Baseline to Week 12 | 14 | 19 |
| Total, other adverse events | ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 | 12 | 19 |
| Total, serious adverse events | ARM A: Dipyridamole for 24 Weeks From Baseline to Week 24 | 0 | 21 |
| Total, serious adverse events | ARM B: Placebo for 12 Weeks From Baseline to Week 12 | 0 | 19 |
| Total, serious adverse events | ARM B: Dipyridamole for 12 Weeks From Week 12 to Week 24 | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI110410 | Dipyridamole as a Modulator of HIV-1 Inflammation by Adenosine Regulation | RIDDLER, SHARON; MACATANGAY, BERNARD JONAS C | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2014 to 2017 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02121756
GET https://conductscience.org/api/trials/v1/NCT02121756/results?page=2