Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003522049711 Date of Registration: 02/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of aspirin on human immunodeficiency virus (hiv) disease progression among hiv- infected individuals initiating antiretroviral therapy.
Official scientific title The effect of aspirin on human immunodeficiency virus (hiv) disease progression among hiv- infected individuals initiating antiretroviral therapy.
Brief summary describing the background and objectives of the trial 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 cause a reduction and maintenance in HIV load, significantly 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 17/02/2020
Actual trial start date 02/03/2020
Anticipated date of last follow up 17/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 454
Actual target sample size (number of participants)
Recruitment status Suspended
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aspirin i.e. acetyl salicylic acid 75 mg once daily for six months six months The participants who are the newly diagnosed HIV infected patients will be receiving 75 mg aspirin tablet once daily for six months in addition to their anti retroviral drugs. The control group will be receiving a placebo for the 75 mg aspirin tablet in addition to their anti retroviral drugs. 227
Control Group placebo one tablet of placebo for 75 mg aspirin taken once daily for six months six months in addition to their ARV drugs, the participants in the control group will be taking one tablet of the placebo for 75 mg aspirin once daily for six months 227 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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) 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/01/2019 National health research ethics subcommittee i.e. NatHREC
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11102 United Republic of Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/09/2018 MUHAS Senate research and publication committee
Ethics Committee Address
Street address City Postal code Country
9 United Nations Road, Kalenga Street, Upanga West Dar es Salaam 11103 United Republic of Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/07/2019 TMDA
Ethics Committee Address
Street address City Postal code Country
Abdul Jumbe Avenue Dodoma 41101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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) 8, 12 and 24 weeks
Secondary Outcome 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. CD4 count, sCD14, sP- selectin, percentage of activated and exhausted T cells measured at 3 and 6 months, clinical responses, compliance to study medications and adverse events measured monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CTC at Temeke Regional Referral Hospital Temeke Street Dar es Salaam United Republic of Tanzania
CTC at Mbagala Rangi Tatu Hospital Zakhem Dar es Salaam United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
HIV Implimentation Science HIS 9 United Nations Road, kalenga Street, Upanga West Dar es Salaam United Republic of Tanzania
HEPI THET 9 United Nations Road, kalenga Street, Upanga West Dar es Salaam United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MUHAS 9 United nations road, kalenga street, upanga west Dar es Salaam United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Professor Ueno 2-39-1 Kurokami Chu-ku Kumamoto 860-8555 Japan Kumamoto Japan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tosi Mwakyandile tosimichaels@yahoo.co.uk +255743712103 9 United nations road, kalenga street, upanga west
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Principal Investigator
Role Name Email Phone Street address
Public Enquiries Bruno Sunguya drp@muhas.ac.tz +255222150302 9 United nations road, kalenga street, upanga west
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania chairman of MUHAS Senate Research and Publications Committee
Role Name Email Phone Street address
Scientific Enquiries Tosi Mwakyandile tosimichaels@yahoo.co.uk +255743712103 9 United nations road, kalenga street, upanga west
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Principal Investigator and PhD student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the respective article, after deidentification (text, tables, figures and appendices). Study Protocol From 9 months and to 36 months after article publication 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.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information