HivPhase 2NCT05525156
The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy
A Phase 2 study testing aspirin enteric coated tablet 75 mg in people with Hiv and Cardiovascular Diseases, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Cardiovascular Diseases
- What is being tested?
- aspirin enteric coated tablet 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- 1 siteTanzania
- Study dates
- 2 Mar 2020to 22 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Mwananyamala Regional Referral Hospital, Mbagala Rangi Tatu Hospital
Dar es Salaam
About this study
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.
Read the detailed description
Despite the introduction of antiretroviral (ARV) therapy, HIV is still a public health problem in Eastern and Southern Africa. The wide spread use of the ARV drugs has improved the life expectancy of people living with HIV and/ or acquired immunodeficiency syndrome (AIDS). As a result, there has been an increase in the prevalence of and mortality from non - AIDS complications such as non - AIDS defining cancers, liver, pulmonary and cardiovascular diseases. The increase in the non - AIDS complications especially the cardiovascular disease risk is linked to platelet and immune activation. Antiretroviral therapy (ART) does not completely abolish the immune activation and the platelet activation making it a necessity to find additional therapy to the conventional ART therapy, that will decrease the occurrence of these non- AIDS complications and their associated morbidities. Aspirin or acetyl salicylic acid (ASA) has shown promise as such an additional drug. In addition, ASA appears to have an array of beneficial effects in the HIV infected individuals. ASA is reported to possibly cause a reduction in HIV load, increase CD4 counts and halt the clinical HIV disease progression. Literature shows that additional therapy to ARV drugs may compromise adherence to ART among HIV- infected individuals. However, when addition of a pill is associated with significant benefit, the addition of a pill or pills may be justifiable. For example, addition of medication for opportunistic infection, methadone maintenance therapy and antidepressants has been reported to improve adherence to ART among HIV- infected patients in some studies. Therefore, considering the reported benefits of ASA in the HIV- infected population, it is important to study the effect of the addition of ASA on both the HIV disease progression and the adherence to ARV drugs. The project aims at investigating the effects of low dose aspirin on immunological, virologic and clinical outcomes among HIV- infected individuals initiating ART.
The investigators hypothesize that addition of ASA to ART in the newly recruited HIV- infected patients will be associated with earlier and sustained virologic suppression, better immunological and clinical responses and improved quality of life. And also that addition of ASA to ART in the newly recruited HIV- infected patients will not compromise adherence to ARV therapy.
- The objectives of the research project: Broad objective: To determine the effect of low dose of ASA on HIV disease progression and adherence to anti- retroviral therapy among HIV-infected individuals initiating ARV therapy.
Specific Objectives i. To compare the HIV viral loads measured at 2, 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
ii. To compare the CD4 counts measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
iii. To compare the plasma levels of immune activation biomarker (sCD14) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
iv. To compare the plasma levels of platelet activation biomarker (P- selectin) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
- To compare percentage of activated T cells (CD38 positive and HLA-DR positive T cells) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA. vi. To compare percentages of exhausted T cells (PD1 positive T cells) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA. vii. To compare morbidity among HIV- infected individuals initiating ARV therapy alone or ARV therapy and 75mg ASA. viii. To compare all-cause-mortality among HIV- infected individuals initiating ARV therapy alone or ARV therapy and 75mg ASA. ix. To determine level of adherence to ARV therapy among HIV- infected individuals initiating ARV therapy and ASA or placebo.
- Conditions
- Hiv, Cardiovascular Diseases
- Being tested
- aspirin enteric coated tablet 75 mg
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin enteric coated tablet 75 mgDrug
Also called antiretroviral drugs
blister packaged enteric coated tablet of 75 mg aspirin taken once daily for 24 weeks in addition to the conventional antiretroviral drugs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: aspirin enteric coated tablet 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
Virologic failure, safety, immunological and clinical responses
Secondary outcomes include proportion of participants with viral load of >1000 copies/mL at the end of 24 weeks, proportion of participants attaining a >30% rise of CD4 count from baseline value at the end of 12 weeks, and prevalence of morbidity and all-cause mortality. Other secondary outcomes are proportion of participants with normal levels of the assessed biomarkers of platelet and immune activation at the end of 12 and 24 weeks, proportion of participants experiencing adverse events, mean percentage adherence to antiretroviral drugs and mean percentage compliance to the study drugs.
Measured: up to 24 weeks for safety, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start2 Mar 2020
- Primary completion22 Jun 2022
- Study completion22 Jun 2023 (estimated)
Why it stopped: The study stopped due to expiry of study drugs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhimbili University of Health and Allied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Kumamoto University
- Responsible party
- Principal investigator, Tosi Michael Mwakyandile, Muhimbili University of Health and Allied Sciences
- Investigators
- Eligius F Lyamuya, MD, MMed, PhD, FTAAS, FCPath, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525156
- Sponsor's protocol ID
- DA.282/298/01 /C
- Other IDs
- PACTR202003522049711, R25TW011227, 5D43TW009775-03
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the respective article, after deidentification (text, tables, figures and appendices).
Publications
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.
PubMed 34728445Mwakyandile 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.
PubMed 40880360
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspirin on HIV Disease Progression Among HIV- Infected Individuals Initiating Anti- Retroviral Therapy
- ClinicalTrials.gov ID
- NCT05525156
- Acronym / sponsor ID
- DA.282/298/01 /C
- Conditions
- Hiv, Cardiovascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study stopped due to expiry of study drugs
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- Muhimbili University of Health and Allied SciencesUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Kumamoto University
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2023 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite the introduction of antiretroviral (ARV) therapy, HIV is still a public health problem in Eastern and Southern Africa. The wide spread use of the ARV drugs has improved the life expectancy of people living with HIV and/ or acquired immunodeficiency syndrome (AIDS). As a result, there has been an increase in the prevalence of and mortality from non - AIDS complications such as non - AIDS defining cancers, liver, pulmonary and cardiovascular diseases. The increase in the non - AIDS complications especially the cardiovascular disease risk is linked to platelet and immune activation. Antiretroviral therapy (ART) does not completely abolish the immune activation and the platelet activation making it a necessity to find additional therapy to the conventional ART therapy, that will decrease the occurrence of these non- AIDS complications and their associated morbidities. Aspirin or acetyl salicylic acid (ASA) has shown promise as such an additional drug. In addition, ASA appears to have an array of beneficial effects in the HIV infected individuals. ASA is reported to possibly cause a reduction in HIV load, increase CD4 counts and halt the clinical HIV disease progression. Literature shows that additional therapy to ARV drugs may compromise adherence to ART among HIV- infected individuals. However, when addition of a pill is associated with significant benefit, the addition of a pill or pills may be justifiable. For example, addition of medication for opportunistic infection, methadone maintenance therapy and antidepressants has been reported to improve adherence to ART among HIV- infected patients in some studies. Therefore, considering the reported benefits of ASA in the HIV- infected population, it is important to study the effect of the addition of ASA on both the HIV disease progression and the adherence to ARV drugs. The project aims at investigating the effects of low dose aspirin on immunological, virologic and clinical outcomes among HIV- infected individuals initiating ART.
The investigators hypothesize that addition of ASA to ART in the newly recruited HIV- infected patients will be associated with earlier and sustained virologic suppression, better immunological and clinical responses and improved quality of life. And also that addition of ASA to ART in the newly recruited HIV- infected patients will not compromise adherence to ARV therapy.
- The objectives of the research project: Broad objective: To determine the effect of low dose of ASA on HIV disease progression and adherence to anti- retroviral therapy among HIV-infected individuals initiating ARV therapy.
Specific Objectives i. To compare the HIV viral loads measured at 2, 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
ii. To compare the CD4 counts measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
iii. To compare the plasma levels of immune activation biomarker (sCD14) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
iv. To compare the plasma levels of platelet activation biomarker (P- selectin) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA.
- To compare percentage of activated T cells (CD38 positive and HLA-DR positive T cells) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA. vi. To compare percentages of exhausted T cells (PD1 positive T cells) measured at 3 and 6 months among HIV- infected individuals after initiating ARV therapy alone or ARV therapy and 75mg ASA. vii. To compare morbidity among HIV- infected individuals initiating ARV therapy alone or ARV therapy and 75mg ASA. viii. To compare all-cause-mortality among HIV- infected individuals initiating ARV therapy alone or ARV therapy and 75mg ASA. ix. To determine level of adherence to ARV therapy among HIV- infected individuals initiating ARV therapy and ASA or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin arm | Experimental | Drug: aspirin enteric coated tablet 75 mgIn 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 |
| Placebo arm | Placebo comparator | Drug: aspirin enteric coated tablet 75 mgIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin enteric coated tablet 75 mgAlso: antiretroviral drugsblister packaged enteric coated tablet of 75 mg aspirin taken once daily for 24 weeks in addition to the conventional antiretroviral drugs | Drug | Aspirin arm, Placebo arm |
Primary outcome
Virologic suppression
Time frame: 8 weeks
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
1 secondary outcome
Virologic failure, safety, immunological and clinical responses
Time frame: up to 24 weeks for safety, 12 and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 34728445Mwakyandile 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.
- Derived from this study: PubMed 40880360Mwakyandile 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the respective article, after deidentification (text, tables, figures and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eligius F Lyamuya, MD, MMed, PhD, FTAAS, FCPath principal investigator
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aspirin enteric coated tablet 75 mg in people with Hiv and Cardiovascular Diseases, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic suppression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.