N/A
Completed N=91
Inducing Immune Quiescence to Prevent HIV Infection in Women
Source: ClinicalTrials.gov NCT02079077 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells — 4.04; 5.55; 4.9; 4.99 percentage of cells
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells |
4.04; 5.55; 4.9; 4.99 | — |
| SECONDARY Change in Number of CCR5+CD4+ T Cell Population at the Female Genital Tract. |
17.60; 22.10 | — |
Eligibility Criteria
Inclusion criteria
- Age greater than 18 years old and less than 50 years old
- Uterus and cervix present
- Willing to take daily acetylsalicylic acid or HCQ
- 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
- Being active in sex work (for the Female commercial sex worker group)
Exclusion criteria
- Age less than 18 years or more than 50 years old
- Pregnancy (if a women becomes pregnant during the 10 weeks of the project she will be excluded)
- Breast feeding
- Pregnant in the last 12 months
- Being positive for Sexual transmissible disease or bacterial vaginosis at week 0
- Menopausal
- No longer involve in sex work (for the female sex worker group)
- Having a chronic disease
- Taking any of the medication listed in annex 1 for health conditions
- Being allergic to acetylsalicylic acid, other medication for pain or fever, tartrazine dye or chloroquine, hydroxuchloroquine, primaquine 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 experienced previous vision changes while taking chloroquine, hydroxychloroquine (Aralen) or primaquine.
- 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
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Data sourced from ClinicalTrials.gov (NCT02079077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.