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NCT05525156

The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy

Suspended Phase 2 Last updated 1 September 2022
What this trial tests

Phase 2 trial testing aspirin enteric coated tablet 75 mg in Hiv in 454 participants. Suspended.

Timeline
2 March 2020
Primary endpoint
22 June 2022
22 June 2023

Quick facts

Lead sponsorMuhimbili University of Health and Allied Sciences
PhasePhase 2
StatusSuspended
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment454
Start date2 March 2020
Primary completion22 June 2022
Estimated completion22 June 2023
Sites1 location across Tanzania

Drugs / interventions tested

Conditions studied

Sponsor

Muhimbili University of Health and Allied Sciences

Who can join

18 and older, any sex, with Hiv or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction An increase in cardiovascular disease (CVD) among people living with HIV infection is linked to platelet and immune activation, a phenomenon unabolished by antiretroviral (ARV) drugs alone. In small studies, aspirin (acetylsalicylic acid \[ASA\]) has been shown to control immune activation, increase CD4+ count, halt HIV disease progression and reduce HIV viral load (HVL). The investigators present a protocol for a larger suspended randomised placebo controlled trial on the effect of an addition of ASA to ARV drugs on HIV disease progression. Methods and analysis A single-centre phase IIA double-blind, parallel-group randomised controlled trial intended to recruit 454 consenting ARV drug-naïve, HIV-infected adults initiating ART. Participants were randomised in blocks of 10 in a 1:1 ratio to receive, in addition to ARV drugs, 75 mg ASA or placebo for 6 months. The primary outcome is the proportion of participants attaining HVL of \<50 copies/mL by 8, 12 and 24 weeks. Secondary outcomes include proportions of participants with HVL of \>1000 copies/mL at week 24, attaining a \>30% rise of CD4 count from baseline value at week 12, experiencing adverse events, with normal levels of biomarkers of platelet and immune activation at weeks 12 and 24 and rates of morbidity and all-cause mortality. Intention-to-treat analysis will be done for all study outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Hypertension and traditional risk factors for cardiovascular diseases among treatment naïve HIV- infected adults initiating antiretroviral therapy in Urban Tanzania.
    Mwakyandile TM, Shayo GA, Sasi PG, Mugusi FM, et al · · 2023 · cited 6× · PMID 37340390 · DOI 10.1186/s12872-023-03332-6
  2. Hypertension and immune activation in antiretroviral therapy naïve people living with human immunodeficiency virus.
    Mwakyandile TM, Shayo GA, Sasi PG, Mugusi FM, et al · · 2024 · cited 1× · PMID 38914935 · DOI 10.1186/s12879-024-09548-x
  3. Low-dose aspirin is not effective as an adjunct treatment for HIV infection among people living with HIV on dolutegravir-based antiretroviral therapy: A randomised double-blind, parallel-group placebo-controlled trial.
    Mwakyandile TM, Shayo GA, Sasi PG, Kunambi PP, et al · · 2025 · PMID 40880360 · DOI 10.1371/journal.pone.0331087

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Other recruiting trials for Hiv

Currently open trials in the same condition.

Other Muhimbili University of Health and Allied Sciences trials

Trials by the same sponsor.

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