Pre-Exposure Prophylaxis for HIV Prevention

(MAPS PrEP Trial)

Overseen By Madelene Travis, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Positive HIV status

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: 3

Duration: 6 months

20 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Pre-Exposure Prophylaxis (PrEP) for HIV prevention?

Clinical trials have shown that PrEP is effective in reducing the risk of acquiring HIV when taken as prescribed. However, adherence to the medication is crucial for its success in preventing HIV infection. ^{1 2 3 4 5}

Is Pre-Exposure Prophylaxis (PrEP) safe for humans?

PrEP, which uses medications like tenofovir disoproxil fumarate/emtricitabine, is generally considered safe based on clinical trials. Some mild side effects like nausea, vomiting, and diarrhea have been reported, and regular monitoring is recommended to prevent long-term issues with liver, kidneys, and bones. ^{1 6 7 8 9}

How is the drug PrEP unique in preventing HIV?

PrEP is unique because it is taken by people who are not yet infected with HIV to prevent infection, using a combination of antiretroviral drugs like Truvada (tenofovir disoproxil fumarate and emtricitabine) before potential exposure to the virus. This proactive approach is different from treatments given after someone has already contracted HIV. ^{5 10 11 12 13}

What is the purpose of this trial?

For this study the investigators aim to see if giving participants an oral HIV prevention medication on a medical van, is a good option of care for individuals who inject drugs and/or are sexually active and therefore at a higher risk of contracting HIV.

Research Team

Jacqueline Hodges, MD, MPH

Principal Investigator

Duke Health

Mehri McKellar, MD

Principal Investigator

Duke Health

Eligibility Criteria

This trial is for individuals who inject drugs and/or are sexually active, putting them at a higher risk of contracting HIV. The study aims to provide oral HIV prevention medication via a medical van.

Inclusion Criteria

I am over 18, use drugs by injection, am sexually active, and was referred by a Syringe Service Program.

Exclusion Criteria

I am HIV positive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Participants receive oral PrEP pills to reduce their risk for contracting HIV

6 months

Visits on a Medical Mobile Unit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HIV status checks

6 months

3 month and 6 month visits

Treatment Details

Interventions

• Pre-Exposure Prophylaxis (PrEP)

Trial Overview The intervention being studied is the distribution of Pre-Exposure Prophylaxis (PrEP), an oral medication that helps prevent HIV infection, through a mobile medical service directly to high-risk populations.

Participant Groups

Group I: PrEP Experimental Treatment 1 Intervention

All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

A study of 61 recent HIV seroconverted patients revealed that 98.4% were men who have sex with men, primarily aged 20 to 39 years, indicating a specific demographic that may benefit from PrEP.

The majority of these individuals engaged in high-risk behaviors, such as multiple unprotected sexual practices (82.7%) and substance use during sex (87%), highlighting the importance of targeted PrEP interventions for those at greatest risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To whom is HIV pre-exposure prophylaxis proposed? Ayerdi-Aguirrebengoa, O., Vera-García, M., Puerta-López, T., et al.[2019]

HIV incidence was found to be 7.5 times higher after individuals stopped using PrEP compared to when they were on it, highlighting the importance of continuous adherence to PrEP for effective HIV prevention.

Barriers to maintaining PrEP included substance use, mental health issues, and difficulties accessing the medication, suggesting that targeted outreach and education could help improve adherence and prevent HIV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities to prevent HIV infections among pre-exposure prophylaxis users: a population-based mixed methods study, San Francisco, United States. Spinelli, MA., Laborde, N., Kinley, P., et al.[2023]

The first German-Austrian PrEP guidelines provide comprehensive recommendations on the effective use of HIV Pre-Exposure Prophylaxis (PrEP) for individuals at risk, emphasizing its role in reducing HIV transmission.

The guidelines outline necessary laboratory tests and monitoring protocols to ensure safety and prevent adverse events while on PrEP, ensuring that healthcare providers have clear guidance for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summary of German-Austrian HIV PrEP guideline. Spinner, CD., Lang, GF., Boesecke, C., et al.[2020]

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

A review of 808 cases of pre-exposure prophylaxis (PrEP) using TDF/FTC revealed that the most common adverse effects (AEs) were gastrointestinal issues, such as nausea, vomiting, and diarrhea, which aligns with known side effects in HIV-infected populations.

Despite identifying 24% of unexpected adverse effects, including serious ones primarily among chemsex users, the overall data supports the safety of PrEP, indicating it is a viable option for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] Jacomet, C., Lebeller, C., Schiestel, T., et al.[2022]

Antiretroviral pre-exposure prophylaxis (PrEP) using oral emtricitabine-tenofovir disoproxil fumarate has been proven effective and safe in preventing HIV infection, leading to regulatory approval in nearly 70 countries.

Ongoing development of next-generation PrEP formulations aims to simplify access and increase user choice, which could enhance coverage and further reduce HIV infection rates at the population level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEP for HIV Prevention: Evidence, Global Scale-up, and Emerging Options. Celum, C., Baeten, J.[2020]

Stampidine is a novel antiretroviral drug candidate that shows strong effectiveness against multidrug-resistant HIV-1, with in vitro potency significantly higher than its required therapeutic levels, making it a promising option for pre-exposure prophylaxis (PrEP).

In preclinical studies, stampidine demonstrated a favorable safety profile, with no observed toxicity in various animal models and no dose-limiting toxicity in a Phase I clinical trial involving human participants, indicating its potential for safe use in preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stampidine as a promising antiretroviral drug candidate for pre-exposure prophylaxis against sexually transmitted HIV/AIDS. Uckun, FM., Cahn, P., Qazi, S., et al.[2013]

The study demonstrated that pre-exposure prophylaxis (PrEP) using Truvada is a highly effective strategy for preventing HIV infection among men who have sex with men, with strong retention and compliance rates observed during the study period from January 2017 to March 2021.

Safety assessments indicated that PrEP was well-tolerated, with no significant adverse events related to Truvada, and regular monitoring of renal function showed no major issues, supporting the safety of this preventive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. Terada-Hirashima, J., Mizushima, D., Takano, M., et al.[2023]

References

1. Spain pubmed.ncbi.nlm.nih.gov

To whom is HIV pre-exposure prophylaxis proposed? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Delayed maturation of antibody avidity but not seroconversion in rhesus macaques infected with simian HIV during oral pre-exposure prophylaxis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Missed opportunities to prevent HIV infections among pre-exposure prophylaxis users: a population-based mixed methods study, San Francisco, United States. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Prescribing of Human Immunodeficiency Virus (HIV) Pre-exposure Prophylaxis by HIV Medical Providers in the United States, 2013-2014. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Summary of German-Austrian HIV PrEP guideline. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Where next with preexposure prophylaxis? [2018]

9. United States pubmed.ncbi.nlm.nih.gov

PrEP for HIV Prevention: Evidence, Global Scale-up, and Emerging Options. [2020]

10. Spain pubmed.ncbi.nlm.nih.gov

PrEP program experience in a hospital HIV unit. Description of baseline user profile and identification of opportunities for improvement. [2023]

11. Spain pubmed.ncbi.nlm.nih.gov

PrEP program experience in a hospital HIV unit. Description of baseline user profile and identification of opportunities for improvement. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Stampidine as a promising antiretroviral drug candidate for pre-exposure prophylaxis against sexually transmitted HIV/AIDS. [2013]

13. Canada pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. [2023]