10 Participants Needed

Cure Therapies for HIV

FC
SM
Overseen BySaurabh Mehandru, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
Must be taking: HIV cure therapies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how potential HIV cure therapies affect the virus and immune cells in the gut. Participants will undergo a colonoscopy, a procedure using a camera to inspect the colon, to collect tissue samples. Researchers will examine these samples for changes in immune cells and viral levels. People living with chronic HIV-1, who are on treatment aiming for a cure and comfortable with undergoing a colonoscopy, may be a good fit for this study. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in HIV cure strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be receiving treatment with a molecule that has the potential for an HIV cure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that some HIV cure therapies can be safe for participants. In one program, participants reported no harmful effects, suggesting that the treatments might be easy to handle. Another study followed a drug called maraviroc for five years, and it was generally safe for those who had used other HIV treatments before. It's important to note that health authorities have not yet approved all HIV cure therapies. While some early results are promising, researchers continue to learn about the safety of these treatments.12345

Why are researchers excited about this trial?

Unlike the standard HIV treatments, which typically involve antiretroviral drugs to manage the virus, this trial is exploring colonoscopy as a potential avenue for an HIV cure. Researchers are excited about this approach because it could uncover new insights into how the gastrointestinal tract might play a role in eliminating the virus from the body. This method is unique as it focuses on a physical procedure rather than medication, potentially paving the way for groundbreaking discoveries in the fight against HIV.

What evidence suggests that this trial's treatments could be effective for HIV?

Studies have shown that treatments for HIV aim to control the virus without ongoing medication. Although a universal cure does not yet exist, researchers are exploring various approaches. In this trial, participants will receive therapies with potential for an HIV cure. Some studies suggest that widespread use of these treatments could significantly reduce new HIV cases. However, effectiveness can vary, and further research is needed to understand long-term effects. The primary goal is to find a treatment that manages the virus and enhances life for people with HIV.16789

Who Is on the Research Team?

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Francesca Cossarini

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with chronic HIV infection who are willing to follow the study procedures. They must be able to undergo a colonoscopy twice and be on a treatment that might cure HIV. People with bowel diseases, other gastrointestinal conditions, coagulation problems, or those pregnant or planning pregnancy can't participate.

Inclusion Criteria

Chronic HIV-1 infection confirmed by licensed tests
Provision of signed and dated informed consent form
I am willing and able to follow the study's requirements.
See 2 more

Exclusion Criteria

Known coagulopathy or altered coagulation studies
Any other condition which in the opinion of investigators would impede competence, compliance, or possibly hinder completion of the study
I currently have a sexually transmitted infection.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects receive therapies with the potential for HIV cure and undergo a colonoscopy to obtain gastrointestinal tissue for research assays

4 weeks
1 visit (in-person for colonoscopy)

Follow-up

Participants are monitored for changes in immune cells and HIV viral load in the gastrointestinal tract

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Colonoscopy
Trial Overview The study aims to see if therapies thought to potentially cure HIV can change immune cells in the gut and lower tissue-associated HIV levels. Participants will have their gastrointestinal tract examined through a colonoscopy before and after receiving these potential cure therapies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Patients with HIV TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Published Research Related to This Trial

In a study of 161 patients with lower gastrointestinal bleeding (LGIB) and 161 matched non-GIB controls, adverse events during bowel preparation and colonoscopy were found to be low, indicating that colonoscopy is generally safe for LGIB patients.
There were no significant differences in adverse events between LGIB and non-GIB patients, even among subgroups such as the elderly or those with comorbidities, suggesting that colonoscopy does not increase risks in these populations.
Adverse Events during Bowel Preparation and Colonoscopy in Patients with Acute Lower Gastrointestinal Bleeding Compared with Elective Non-Gastrointestinal Bleeding.Niikura, R., Nagata, N., Shimbo, T., et al.[2022]
Colonoscopy is generally safe, with an adverse event rate of 2.8 per 1000 procedures, but serious complications like hemorrhage and perforation are more common when polypectomy is performed.
The article emphasizes the importance of preventing and managing adverse events specifically related to polypectomy and endoscopic mucosal resection of colonic lesions.
Adverse events related to colonic endoscopic mucosal resection and polypectomy.Sethi, A., Song, LM.[2022]
A study of 53,220 elderly Medicare beneficiaries found that those undergoing outpatient colonoscopy had a higher risk of serious gastrointestinal events, such as bleeding and perforation, compared to matched individuals who did not have the procedure.
The risk of adverse events increased with age and was notably higher in patients undergoing polypectomy, as well as in those with specific comorbid conditions like stroke or chronic obstructive pulmonary disease.
Adverse events after outpatient colonoscopy in the Medicare population.Warren, JL., Klabunde, CN., Mariotto, AB., et al.[2022]

Citations

The long‐term impact and value of curative therapy for HIVCurative therapies (CTx) to achieve durable remission of HIV disease without the need for antiretroviral therapy (ART) are currently being explored.
Current developments in HIV treatment and preventionCurrently, there is no universally effective cure for HIV infection and AIDS. ... efficacy outcomes from key vaccine and immunotherapy trials. These points ...
Model-based evaluation of the impact of a potential HIV ...Mean reductions in cumulative HIV infections over this period, compared to the no-cure scenario, ranged from 60% (95%CrI 21–72%) for 90% uptake ...
Gilead Presents New HIV Research Data at EACS 2025The five-year outcomes are consistent with the results observed from multiple Phase 3 clinical trials evaluating the treatment responses of ...
The Effectiveness of Antiretroviral Therapy in Mitigating ...This study utilized real-world data to evaluate the community-level effectiveness of ART in reducing new HIV infections.
Merck to Present New Data from HIV Treatment and ...An oral presentation of 96 weeks of safety and pharmacokinetics data from the Phase 2 trial ( NCT05052996) of the investigational once-weekly ...
HIV cure: ending the HIV epidemicThis treatment aims to cure HIV and is being tested in a clinical trial that is expected to finish in March 2025.
Five-Year Safety Evaluation of Maraviroc in HIV-1–Infected ...Conclusions: Maraviroc was generally safe in treatment-experienced participants for >5 years. Key Words: maraviroc, CCR5 antagonist, HIV, ...
HIV Cure Program Releases Initial Clinical Trial Data... HIV cure program without modification, after safety analysis of the participant's data revealed no adverse effects from the treatment. AGT's ...
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