The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti-… (NCT05525156) | Clinical Trial Compass
SuspendedPhase 2
The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy
Stopped: The study stopped due to expiry of study drugs
Tanzania454 participantsStarted 2020-03-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Consenting newly recruited male or female HIV-infected patients
* Antiretroviral drug-naïve initiating on antiretroviral drugs
* Age 18 years or older
* Willingness to stay in Dar es Salaam for at least 6 consecutive months
* Willingness to attend HIV clinics at Temeke or Mbagala Rangi Tatu or Mwananyamala hospital for at least six consecutive months
Exclusion Criteria:
* Previous intolerance or allergy to aspirin or any aspirin products
* Asthmatics
* Predisposition to bleeding (increased chance of bleeding due to being on antiplatelets and/or anticoagulants and/or having history of or active diagnosis of bleeding disorder)
* Antithrombotic therapy
* Therapy with protocol prohibited drugs
* Active or history of peptic ulcer disease
* Pregnancy
* Severe renal disease (eGFR \<30 mil/min/1.73 m2)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Virologic suppression
Timeframe: 8 weeks
Trial details
NCT IDNCT05525156
SponsorMuhimbili University of Health and Allied Sciences