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

NCT05525156 | Suspended Phase 2 DMC

• 4 other identifiers: DA.282/298/01 /CPACTR202003522049711R25TW0112275D43TW009775-03
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief 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

Hiv; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Virologic suppression

  The primary outcome is the proportion of participants attaining viral load of \<50 copies/mL at the end of 8, 12 and 24 weeks. I

  8 weeks

Secondary Outcomes (1)

• Virologic failure, safety, immunological and clinical responses

  up to 24 weeks for safety, 12 and 24 weeks

Study Arms (2)

Aspirin arm

EXPERIMENTAL

In addition to their antiretroviral regimen, participants self administer blister packaged enteric coated tablet of 75 mg aspirin (Cardisprin 75, Cosmos, Nairobi, Kenya) for 24 weeks at a dose of one tablet per day at evening times swallowed wholly with a glass of clean drinking water, preferably after a meal. All adults initiating antiretroviral therapy are prescribed the default combination of tenofovir (TDF) +lamivudine (3TC)+dolutegravir (DTG). Those with contraindications are alternatively prescribed abacavir+3TC+DTG or TDF +3TC+efavirenz and in special situations zidovudine+3TC+DTG

Drug: aspirin enteric coated tablet 75 mg

Placebo arm

PLACEBO COMPARATOR

In addition to their antiretroviral regimen, participants self administer blister packaged placebo (Cardisprin 75, Cosmos, Nairobi, Kenya) for 24 weeks at a dose of one tablet per day at evening times swallowed wholly with a glass of clean drinking water, preferably after a meal. The placebo has colour, shape and size similar to aspirin

Drug: aspirin enteric coated tablet 75 mg

Interventions

aspirin enteric coated tablet 75 mg DRUG

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

Also known as: antiretroviral drugs

Aspirin arm; Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Muhimbili University of Health and Allied Sciences: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Kumamoto University: collaborator

Study Sites (1)

Mwananyamala Regional Referral Hospital, Mbagala Rangi Tatu Hospital

Dar es Salaam, Tanzania

Location

Related Publications (2)

• Mwakyandile T, Shayo G, Mugusi S, Sunguya B, Sasi P, Moshiro C, Mugusi F, Lyamuya E. Effect of aspirin on HIV disease progression among HIV-infected individuals initiating antiretroviral therapy: study protocol for a randomised controlled trial. BMJ Open. 2021 Nov 2;11(11):e049330. doi: 10.1136/bmjopen-2021-049330.

  PMID: 34728445 BACKGROUND

• Mwakyandile TM, Shayo GA, Sasi PG, Kunambi PP, Mugusi FM, Barabona G, Ueno T, Lyamuya EF. 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. PLoS One. 2025 Aug 29;20(8):e0331087. doi: 10.1371/journal.pone.0331087. eCollection 2025.

  PMID: 40880360 DERIVED

Related Links

• study protocol paper

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Eligius F Lyamuya, MD, MMed, PhD, FTAAS, FCPath

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 1, 2022
• Study Start: March 2, 2020
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 9 months and to 36 months after article publication
• Access Criteria: Investigators with approval by an independent review committee for proposed use of data. Data will be shared for individual participant data meta analysis The mechanism by which data will be made available is that proposals may be submitted up to 36 months after respective article publication. after this period data will be made available at MUHAS data warehouse but without investigator support other than deposited metadata.

Locations

TA (1)