Inducing Immune Quiescence to Prevent HIV Infection in Women

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

In this project, the investigators want to analyse the capacity of Acetylsalicylic acid and hydoxychlroquin (HCQ) to induce an Immune Quiescence (IQ) phenotype, which has been previously associated with natural protection to HIV infection. 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 ( female genital tract).

The objective of this study is to determine if daily oral administration of Acetylsalicylic acid or hydroxychlroroquin can reduce systemic and mucosal immune activation in HIV negative women.

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

Details

• Lead Sponsor: University of Manitoba
• Collaborator: University of Nairobi
• Treatments: Aspirin; Hydroxychloroquine

Criteria

Inclusion criteria:

1. Age greater than 18 years old and less than 50 years old

2. Uterus and cervix present

3. Willing to take daily acetylsalicylic acid or HCQ

4. Willing to undergo pelvic exams

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

6. Being HIV negative

7. Without any cardiovascular disease

8. Being active in sex work (for the Female commercial sex worker group)

Exclusion criteria:

1. Age less than 18 years or more than 50 years old

2. Pregnancy (if a women becomes pregnant during the 10 weeks of the project she will be excluded)

3. Breast feeding

4. Pregnant in the last 12 months

5. Being positive for Sexual transmissible disease or bacterial vaginosis at week 0

6. Menopausal

7. No longer involve in sex work (for the female sex worker group)

8. Having a chronic disease

9. Taking any of the medication listed in annex 1 for health conditions

10. Being allergic to acetylsalicylic acid, other medication for pain or fever, tartrazine dye or chloroquine, hydroxuchloroquine, primaquine or any other medication

11. 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

12. Having experienced previous vision changes while taking chloroquine, hydroxychloroquine (Aralen) or primaquine.

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

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

15. Having anemia

16. Current participation in a clinical trial

-

-