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

NCT05525156 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2022-09-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

aspirin enteric coated tablet 75 mg

blister packaged enteric coated tablet of 75 mg aspirin taken once daily for 24 weeks in addition to the conventional antiretroviral drugs

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Kumamoto University

    collaborator OTHER

  • Muhimbili University of Health and Allied Sciences

    lead OTHER

Principal Investigators

  • Eligius F Lyamuya, MD, MMed, PhD, FTAAS, FCPath · Muhimbili University of Health and Allied Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-06-22
Completion
2023-06-22

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525156 on ClinicalTrials.gov