Inducing Immune Quiescence the Genital Tract With ASA

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

There are 33.4 million individuals living with HIV/AIDS worldwide. Despite successful HIV prevention strategies such as condom use and reduction of sexual partners, HIV continues to spread at an alarming rate. In 2010, 2.6 millions of new infections were detected. In Sub-Saharan Africa, women represent the two-third of all new infections1. Despite the efforts of the scientific community, there is still no commercial vaccine or microbicide available.

To explain this natural protection against HIV, different mechanisms have been identified. These women have a unique immune phenotype that we called Immune Quiescence. This phenotype is characterized by lower expression of genes involved in cellular activation, lower resting levels of inflammatory cytokine production, lower level of systemic activated T cells, increased levels of systemic T regulatory, increased production of anti-viral anti-protease serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+ CCR5+ T cells) in the FGT This project aims to induce an Immune Quiescence phenotype (decreasing immune activation) to prevent HIV infection

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Manitoba
• Collaborator: Bayer
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Age greater of 18 years and less than 45

• Be active in sex work for five years or less

• Uterus and cervix present

• Willing to take daily the study drug (acetylsalicylic acid)

• Willing to undergo pelvic exams

• In general good health, no chronic infection and not taking any anti-inflammatory or immunosuppressors

• Being HIV negative

• Without any cardiovascular disease

Exclusion Criteria:

• Age less than 18 or more than 45

• Breastfeeding

• Pregnant in the last 12 months

• Presence of sexual transmissible disease or bacterial vaginosis at enrollment

• Menopausal

• Pregnancy (if a women becomes pregnant during the study she will be excluded)

• Not being involve in sex work or being involved in sex work for more than 6 years

• Having a chronic disease

• Consumption of the medication listed in appendix entitled: list of other medication for health conditions

• Being allergic to acetylsalicylic acid, other medication for pain or fever, tartrazine or any other medication

• Having heartburn, stomach pain, stomach ulcer, anemia, hemophilia, kidney or liver disease, psoriasis, porphyria or other blood disease, G-6-PD deficiency, dermatitis (skin inflammation), alcoholism

• Having a history of a diagnosed cardiovascular event, heart failure, peripheral arterial disease, angina, stoke, transient ischemic attack

• Having a current or recurrent condition with a high risk of major bleeding

• Having anemia

• Current participation in a clinical trial