HIVIIQ-2NCT03629327
Inducing Immune Quiescence the Genital Tract With ASA
A study testing ASA 81mg and ASA 325mg in people with HIV, run by University of Manitoba at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- ASA 81mg and ASA 325mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteKenya
- Study dates
- 10 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Kenyan Aids Control Project/University of Nairobi
Nairobi
Joshua Kimani, Dr., jkimani@csrtkenya.org
About this study
Official title: Preventing HIV Infection by Targeting the Immune System Instead of the Virus
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
Read the detailed description
HIV is an important global health issue. Globally, HIV is mostly transmitted through heterosexual sexual activity, and women bear the brunt of the pandemic as two-third are in women. New preventive strategies need to be developed to empower women to protect themselves. In Nairobi, Kenya, there are around 27 000 sex workers and despite prevention efforts, HIV incidence is very high in this vulnerable group which serves as catalyzers for HIV transmission to the community. Among those sex workers, despite being at higher risk of infection, some rare individuals remain HIV exposed seronegative (HESN). Over the years, our group has tried to understand this natural protection to HIV infection. The investigators discovered that in HESN individuals, the basal level of activation of the immune system is lower than in other people. This includes having few HIV target cells, mainly CD4+ CCR5+ T cells, in their genital tract. The investigators called this special phenotype Immune Quiescence (IQ). In a recent pilot study (Limiting HIV target cells by Inducing Immune Quiescence in the female genital tract ) the investigators showed that in non-sex worker women it is possible to decrease the proportion of HIV target cells and/or HIV co-receptor at the female genital tract by using anti-inflammatory drugs.
Herein, the investigators are proposing to conduct a follow-up study in female sex workers to determine the best drug formulation and drug size effect on reducing HIV target cell number at the female genital tract (FGT). Participants will receive acetylsalicylic acid (ASA) (81mg/day), ASA (325mg/day), or nothing for five months. At visit 1, the baseline immune activation level of the participants will be determined. In this way, every woman will serve as her own control thereby reducing the variation between tested and control groups. Participants will be randomized and ask to take the drug daily. Participants will be followed on a monthly basis. At each study visit, blood, cervico-vaginal lavage and cervical cells will be taken to determine the level of immune activation. This study is a critical "second step" in the rational development of HIV preventive biomedical method.
- Conditions
- HIV
- Being tested
- ASA 81mg, Control Group, ASA 325mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA 81mgDrug
Also called Acetylsalicylic acid 81mg
Participants will be randomized to take 81mg orally on a daily basis for a duration of 6 months
Control GroupOther
Also called no drug
Participants will be randomized to take nothing on a daily basis for a duration of 6 months
ASA 325mgDrug
Also called Acetylsalicylic acid 325mg
Participants will be randomized to take 325mg orally on a daily basis for a duration of 6 months
| Study group | Role | What they receive |
|---|---|---|
| ASA 325mg | Active comparator | Daily uptake of 325mg ASA Receives: Drug: ASA 325mg |
| No drug | Active comparator | no drug Receives: Other: Control Group |
| ASA 81mg | Active comparator | daily uptake of 81mg ASA Receives: Drug: ASA 81mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at each month; For six months following enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start10 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arms will be followed simultaneously
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Keith Fowke, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629327
- Sponsor's protocol ID
- HS19749(B2016:042)
- Other IDs
- B2016:042
- Acronym
- IIQ-2
- Status last verified
- Oct 2023
- First submitted
- 30 Jul 2018
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we are not planing to share individuals data
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing HIV Infection by Targeting the Immune System Instead of the Virus
- ClinicalTrials.gov ID
- NCT03629327
- Acronym / sponsor ID
- IIQ-2 / HS19749(B2016:042)
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
HIV is an important global health issue. Globally, HIV is mostly transmitted through heterosexual sexual activity, and women bear the brunt of the pandemic as two-third are in women. New preventive strategies need to be developed to empower women to protect themselves. In Nairobi, Kenya, there are around 27 000 sex workers and despite prevention efforts, HIV incidence is very high in this vulnerable group which serves as catalyzers for HIV transmission to the community. Among those sex workers, despite being at higher risk of infection, some rare individuals remain HIV exposed seronegative (HESN). Over the years, our group has tried to understand this natural protection to HIV infection. The investigators discovered that in HESN individuals, the basal level of activation of the immune system is lower than in other people. This includes having few HIV target cells, mainly CD4+ CCR5+ T cells, in their genital tract. The investigators called this special phenotype Immune Quiescence (IQ). In a recent pilot study (Limiting HIV target cells by Inducing Immune Quiescence in the female genital tract ) the investigators showed that in non-sex worker women it is possible to decrease the proportion of HIV target cells and/or HIV co-receptor at the female genital tract by using anti-inflammatory drugs.
Herein, the investigators are proposing to conduct a follow-up study in female sex workers to determine the best drug formulation and drug size effect on reducing HIV target cell number at the female genital tract (FGT). Participants will receive acetylsalicylic acid (ASA) (81mg/day), ASA (325mg/day), or nothing for five months. At visit 1, the baseline immune activation level of the participants will be determined. In this way, every woman will serve as her own control thereby reducing the variation between tested and control groups. Participants will be randomized and ask to take the drug daily. Participants will be followed on a monthly basis. At each study visit, blood, cervico-vaginal lavage and cervical cells will be taken to determine the level of immune activation. This study is a critical "second step" in the rational development of HIV preventive biomedical method.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arms will be followed simultaneously
| Arm | Type | Receives |
|---|---|---|
| ASA 325mg | Active comparator | Drug: ASA 325mgDaily uptake of 325mg ASA |
| No drug | Active comparator | Other: Control Groupno drug |
| ASA 81mg | Active comparator | Drug: ASA 81mgdaily uptake of 81mg ASA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA 81mgAlso: Acetylsalicylic acid 81mgParticipants will be randomized to take 81mg orally on a daily basis for a duration of 6 months | Drug | ASA 81mg |
| Control GroupAlso: no drugParticipants will be randomized to take nothing on a daily basis for a duration of 6 months | Other | No drug |
| ASA 325mgAlso: Acetylsalicylic acid 325mgParticipants will be randomized to take 325mg orally on a daily basis for a duration of 6 months | Drug | ASA 325mg |
Primary outcome
Changes in the proportion of HIV Target cells (CD4+CCR5+)
Time frame: Baseline and at each month; For six months following enrolment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No. we are not planing to share individuals data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASA 81mg and ASA 325mg in people with HIV, run by University of Manitoba at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith R Fowke, PhD (204-789-3296, keith.fowke@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the proportion of HIV Target cells (CD4+CCR5+) (time frame: Baseline and at each month; For six months following enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.