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.
b. 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.
v. 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.
