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

• Status: Suspended
• Trial end date: 2023-06-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborators: Fogarty International Center of the National Institute of Health; Kumamoto University
• Treatments: Aspirin

Criteria

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)