The effect of aspirin on human immunodeficiency virus (hiv) disease progression among hiv- infected individuals initiating antiretroviral therapy.

Conditions

HIV/AIDS

Tosi Mwakyandile, Grace Shayo, Philip Sasi, Peter P. Kunambi, Ferdinand Mugusi et al. (8 authors)

PLoS ONE2025-08-29

10.1371/journal.pone.0331087

Trial study protocol.

Tosi M. Mwakyandile (16408705), Grace A. Shayo (15198131), Philip G. Sasi (16408708), Peter P. Kunambi (12878497), Ferdinand M. Mugusi (7372538) et al. (8 authors)

OPAL (Open@LaTrobe) (La Trobe University)2025-08-29

10.1371/journal.pone.0331087.s014

Effect of aspirin on HIV disease progression among HIV-infected individuals initiating antiretroviral therapy: study protocol for a randomised controlled trial

Tosi Mwakyandile, Grace Shayo, Sabina Mugusi, Bruno Sunguya, Philip Sasi et al. (8 authors)

BMJ Open2021-11-0112 citations

10.1136/bmjopen-2021-049330

Interventions

Aspirin i.e. acetyl salicylic acid

placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consenting newly recruited male or female HIV-infected patients ARV drugs naïve initiating on ARV drugs Aged 18 years and above Willing to stay in Dar es salaam for at least six consecutive months Willing to attend HIV clinics at Temeke or Mbagala Rangi Tatu or Mwananyamala hospitals for at least six consecutive months

Exclusion criteria

Exclusion criteria: Previous intolerance or allergy to ASA or any ASA products Asthmatics Current or History of recurrent Peptic Ulcer Disease (PUD) Predisposition to bleeding Antithrombotic therapy Therapy with prohibited drugs (see appendix 5) Active or history of peptic ulcer disease Pregnancy Severe renal disease (eGFR <30 mil/min/1.73 m2)

Design outcomes

Primary

Measure	Time frame
The primary outcome will be virological response i.e. the proportion of patients in the two arms reaching viral loads of < 50 copies/ millilitre at months 2, 3 and 6 (indicating viral suppression)	—

Secondary

Measure	Time frame
The secondary outcomes will be immunologic response measured by CD4 count and clinical responses measured by morbidity and death from any cause. Other secondary outcome measures will be plasma levels of sCD14 and sP- selectin, percentage of activated T cells (CD38 positive and HLA-DR positive T cells), percentage of exhausted T-cells (PD-1 positive T cells), percentage adherence to ART and compliance to study medications, adverse events.	—

Measure

Time frame

The secondary outcomes will be immunologic response measured by CD4 count and clinical responses measured by morbidity and death from any cause. Other secondary outcome measures will be plasma levels of sCD14 and sP- selectin, percentage of activated T cells (CD38 positive and HLA-DR positive T cells), percentage of exhausted T-cells (PD-1 positive T cells), percentage adherence to ART and compliance to study medications, adverse events.

—

Countries

United Republic of Tanzania

Contacts

Public ContactBruno Sunguya

chairman of MUHAS Senate Research and Publications Committee

drp@muhas.ac.tz+255222150302

Outcome results

None listed