Phase 2
Completed N=40
Dipyridamole for Immune Activation in HIV
Source: ClinicalTrials.gov NCT02121756 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 — 244500.00; -58250.00 pg/ml — p=0.8220
Summary
The purpose of this study is to determine if Dipyridamole (DP) will decrease inflammation in HIV-1-infected individuals who are already on antiretroviral treatment and have a low viral load.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12 |
244500.00; -58250.00 | 0.8220 |
| PRIMARY Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12 |
-6.19; 5.42 | 0.0869 |
| PRIMARY Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12 |
-0.02; -0.07 | 0.5027 |
| 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 |
-0.05; 0.00 | 0.4548 |
| SECONDARY Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations |
12; 10; 2; 1; 4; 0 | — |
| 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 |
-0.15; -0.05 | 0.7556 |
| 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 |
-0.25; 0.10 | 0.2075 |
| 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 |
-0.85; 0.25 | 0.0315 sig |
| 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 |
0.00; 0.00 | 0.7376 |
| SECONDARY Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells |
-0.20; 0.05 | 0.2343 |
| SECONDARY Systemic Inflammatory Biomarkers: Change in the Levels of sTNFαR |
-84.61; 34.26 | 0.7598 |
| SECONDARY Systemic Inflammatory Biomarkers: Change in the Levels of TNFα |
-152.31; 123.88 | 0.9830 |
| SECONDARY Systemic Inflammatory Biomarkers: Change in the Levels of hsCRP |
-233.57; -750.35 | 0.3317 |
| SECONDARY Coagulation Biomarkers: Change in the Levels of D-dimer |
45.86; 36.35 | 0.6121 |
| SECONDARY Changes in Brachial Artery Flow-mediated Dilation (FMD) |
0.1; -1.1 | 0.5620 |
Eligibility Criteria
Inclusion Criteria
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- On ART for at least 12 months prior to study entry with a regimen that includes three or more antiretroviral medications. More information on this criterion is available in the protocol.
- Plasma HIV-1 RNA 100.4°F [38°C]) within 4 weeks of study entry.
- Uncontrolled hypertension defined as systolic > 160 mm Hg or diastolic > 100 mm Hg from an average of two or more readings. Participant with controlled hypertension may undergo spirometry.
- Prior history of adverse reaction to albuterol.
Data sourced from ClinicalTrials.gov (NCT02121756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.