Cure Therapies for HIV

Overseen By Saurabh Mehandru, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: HIV cure therapies

Disqualifiers: Coagulopathy, Pregnancy, Inflammatory Bowel Disease, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to understand the effects of HIV cure strategies on the virus and immune cells that reside within the gastrointestinal tract. Subjects receiving therapies with the potential for HIV cure will undergo a colonoscopy to obtain gastrointestinal tissue for research assays. This study will test whether receiving these therapies will induce changes in the immune cells in the gastrointestinal tract and reduce the tissue-associated HIV viral levels.

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 colonoscopy generally safe for humans?

Colonoscopy is generally safe, but it can have some risks. Serious complications like bleeding and perforation (a tear in the colon) are rare, occurring in less than 1% of cases. Most complications are managed successfully, but it's important to be aware of these risks. ^{1 2 3 4 5}

How does this treatment for HIV differ from other treatments?

The treatment in the clinical trial is unique because it focuses on a novel mechanism of action involving anti-α4β7 integrin therapy, which is not a standard approach for HIV. This therapy has been used in managing Crohn's disease in patients with HIV, suggesting a potential new pathway for treating HIV itself. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Colonoscopy, Colon Examination, Lower GI Endoscopy for HIV?

Endoscopy is effective in diagnosing gastrointestinal issues in HIV patients, as it helps identify infections like cytomegalovirus (CMV) and other complications, which are common in these patients. This diagnostic capability can lead to better-targeted treatments for managing HIV-related gastrointestinal symptoms. ^{11 12 13 14 15}

Who Is on the Research Team?

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.

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.

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?

Group I: Patients with HIV Therapy Experimental Treatment 1 Intervention

Subjects receiving therapies with the potential for HIV cure

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after outpatient colonoscopy in the Medicare population. Warren, JL., Klabunde, CN., Mariotto, AB., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. Sethi, A., Song, LM.[2022]

Citations

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

Diagnostic yield and cost-effectiveness of endoscopy in chronic human immunodeficiency virus-related diarrhea. [2019]

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

Idiopathic colonic inflammation in AIDS: an open trial of prednisone. [2013]

3. Spain pubmed.ncbi.nlm.nih.gov

[Gastrointestinal disease due to cytomegalovirus in patients infected with the human immunodeficiency virus]. [2006]

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

Human immunodeficiency virus-associated gastrointestinal disease: common endoscopic biopsy diagnoses. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Gastrointestinal cytomegalovirus manifestations in AIDS]. [2009]

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

Adverse Events during Bowel Preparation and Colonoscopy in Patients with Acute Lower Gastrointestinal Bleeding Compared with Elective Non-Gastrointestinal Bleeding. [2022]

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

Adverse events related to colonoscopy: Global trends and future challenges. [2020]

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

Adverse events after outpatient colonoscopy in the Medicare population. [2022]

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

Adverse events related to colonic endoscopic mucosal resection and polypectomy. [2022]

10. Iran pubmed.ncbi.nlm.nih.gov

Complications of Colonoscopy and its Management: A Single Gastroenterologist Experience. [2020]

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

New Diagnosis of Acquired Immunodeficiency Syndrome in a Patient With Crohn's Disease. [2020]

12. China pubmed.ncbi.nlm.nih.gov

[Treatment of ulcerative colitis by total colectomy ileal pouch-anal anastomosis]. [2018]

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

Diagnosis and management of inflammatory bowel disease. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Current pharmacotherapy of cryptosporidiosis: an update of the state-of-the-art. [2022]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Drug treatment of chronic inflammatory bowel diseases: current status and prospects]. [2006]