Inducing Immune Quiescence the Genital Tract With ASA

NCT03629327 | Unknown DMC

• 2 other identifiers: HS19749(B2016:042)B2016:042
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Changes in the proportion of HIV Target cells (CD4+CCR5+)

  Fresh cervical mononuclear cell populations from the cytobrush/scraper will be stained with monoclonal antibodies, and analyzed by flow cytometry. Proportion of CD4+CCR5+ T cells will be assessed at baseline and over the course of the study.

  Baseline and at each month; For six months following enrolment

Study Arms (3)

ASA 325mg

ACTIVE COMPARATOR

Daily uptake of 325mg ASA

Drug: ASA 325mg

No drug

ACTIVE COMPARATOR

no drug

Other: Control Group

ASA 81mg

ACTIVE COMPARATOR

daily uptake of 81mg ASA

Drug: ASA 81mg

Interventions

ASA 81mg DRUG

Participants will be randomized to take 81mg orally on a daily basis for a duration of 6 months

Also known as: Acetylsalicylic acid 81mg

ASA 81mg

Control Group OTHER

Participants will be randomized to take nothing on a daily basis for a duration of 6 months

Also known as: no drug

No drug

ASA 325mg DRUG

Participants will be randomized to take 325mg orally on a daily basis for a duration of 6 months

Also known as: Acetylsalicylic acid 325mg

ASA 325mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Be a female. Having a female genital tract with a uterus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Kenyan Aids Control Project/University of Nairobi

Nairobi, Kenya

RECRUITING

MeSH Terms

Interventions

Aspirin; Control Groups

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Keith R Fowke, PhD

CONTACT

204-789-3296; keith.fowke@umanitoba.ca

Julie Lajoie, PhD

CONTACT

204-789-3296; julie.lajoie@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three arms will be followed simultaneously

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 14, 2018
• Study Start: January 10, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)