PrEP for HIV Prevention

(OAT-PrEP Trial)

Recruiting at 5 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Cara Spence

Must be taking: Opioid agonist therapy

Disqualifiers: Low creatine clearance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well individuals accept and adhere to taking a pill called PrEP (pre-exposure prophylaxis), which helps prevent HIV, alongside a treatment for opioid use, in pharmacies in Alberta and Saskatchewan. Researchers also seek to determine if there is interest in a long-lasting injection for HIV prevention as an alternative to pills. Suitable candidates are HIV-negative, regularly attend an opioid treatment program, and engage in behaviors that could expose them to HIV. As a Phase 4 trial, this research explores how the already FDA-approved treatment benefits a broader patient population.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking any medication that is not safe to use with the trial drugs. It's best to discuss your current medications with the trial team.

What is the safety track record for pre-exposure prophylaxis (PrEP)?

Research has shown that PrEP (pre-exposure prophylaxis) is generally safe for preventing HIV. Studies indicate that most people in clinical trials tolerate PrEP well, meaning it usually doesn't cause serious side effects.

However, a precaution exists. If someone already has HIV when starting PrEP, there is a risk of developing medication-resistant HIV strains. Therefore, testing for HIV before starting PrEP is crucial.

In summary, PrEP is considered safe for most people when used correctly. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about PrEP for HIV prevention because it offers a proactive way to reduce the risk of contracting HIV before exposure. Unlike traditional HIV treatment options that focus on managing the virus after infection, PrEP involves taking a daily pill to block HIV before it can establish an infection. This method is particularly beneficial for individuals at high risk, offering them a preventative measure rather than waiting for potential exposure and treatment afterward. By potentially lowering transmission rates, PrEP represents a significant advancement in HIV prevention strategies.

What is the effectiveness track record for pre-exposure prophylaxis (PrEP) in HIV prevention?

Research has shown that PrEP (pre-exposure prophylaxis) is highly effective at preventing HIV. Studies have found that PrEP can reduce the risk of contracting HIV by about 99% when taken as directed. In everyday use, PrEP is associated with a 60% lower risk of HIV, which can increase to 93% with regular use. Clinical trials have demonstrated an 86% reduction in HIV infection among men who have sex with men when PrEP is used correctly. With such strong evidence, PrEP is widely accepted as a powerful tool for preventing HIV. Participants in this trial will be divided into two groups: those who agree to take PrEP and those who decline. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Diffuse Large B-Cell Lymphoma and HIV/AIDS who are on opioid replacement therapy. It's designed to see if they can take HIV prevention pills (PrEP) at the same time as their opioid treatment at pharmacies in Alberta and Saskatchewan.

Inclusion Criteria

HIV negative

Ongoing behaviors with potential HIV exposure as assessed by a clinician

Regularly engaged with their respective OAT program at least 3 days a week for the past 2 weeks

Exclusion Criteria

Deemed appropriate by a clinician for HIV Post-Exposure Prophylaxis at the time of screening or enrollment

My kidney function is poor, or I can't take specific HIV medications.

I have taken PrEP in the last 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral PrEP and opioid agonist therapy (OAT) simultaneously in existing pharmacy-based programs

12 months

Monthly visits for data collection and interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment, with interviews assessing changes in understanding and attitudes towards PrEP

12 months

Follow-up visits at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pre-exposure prophylaxis (PrEP)

Trial Overview The study tests how well people handle taking oral PrEP for HIV prevention along with their regular opioid agonist therapy (OAT). The goal is to understand how patients follow this regimen, whether they like it, and if they're interested in long-lasting injectable options instead.

How Is the Trial Designed?

Group I: PrEP Group Experimental Treatment 1 Intervention

Participants who have agreed to be on PrEP

Group II: Non-PrEP Group Active Control 1 Intervention

Participants who have declined PrEP

Who Is Running the Clinical Trial?

Cara Spence

Lead Sponsor

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9096492/

Oral pre-exposure prophylaxis (PrEP) to prevent HIV PrEP is effective in preventing HIV acquisition in MSM with a rate reduction of 75%. HIV infection: MSM, trials with high (≥80%) adherence, 66 per 1000, 9 per ...

2. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(22)00106-2/fulltext

Real-world effectiveness of pre-exposure prophylaxis in ... We found that PrEP use was associated with an overall 60% reduction in the risk of HIV infection, reaching 93% for a high amount of PrEP consumption, and 86% if ...

3. ahrq.gov ahrq.gov/data/visualizations/hiv-prep.html

Effectiveness of Pre-Exposure Prophylaxis To Prevent HIV ... The outcomes shown are HIV infection, mortality, and various other harms. The data are organized by the following study drugs and comparisons: oral PrEP ( ...

4. academic.oup.com academic.oup.com/ofid/article/12/9/ofaf539/8246006

HIV Oral Pre-exposure Prophylaxis Effectiveness, Adherence ... Data from randomized clinical trials have demonstrated its efficacy in preventing HIV infection in people at high risk, reaching 86% in men who ...

5. cdc.gov cdc.gov/stophivtogether/hiv-prevention/prep.html

Talk PrEP Together | HIV Prevention | Let's Stop ... PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed. Although there is less information about how effective PrEP pills are among ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35545381/

Oral pre-exposure prophylaxis (PrEP) to prevent HIV PrEP was found to be safe, but unrecognised HIV at enrolment increased the risk of viral drug resistance mutations. Evidence for behaviour ...

7. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/perinatal/pre-exposure-prophylaxis-prep-prevent-hiv

Pre-exposure Prophylaxis (PrEP) to Prevent HIV During ... Of the FDA-approved PrEP agents for receptive vaginal exposure, TDF/FTC is currently the only option with published safety data in pregnancy and ...

8. cdc.gov cdc.gov/hivnexus/hcp/prep/index.html

Clinical Guidance for PrEP | HIV Nexus Daily oral PrEP with F/TAF is recommended to prevent HIV through sexual transmission, excluding people likely to get HIV through receptive vaginal sex. F/TAF ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362649/

Pre-Exposure Prophylaxis for HIV Prevention: Safety ... PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials.