Surgical removal of eye-surface squamous tumors in people living with HIV in Sub-Saharan Africa
Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)
We will try surgical removal of suspected eye-surface squamous tumors in people living with HIV in sub‑Saharan Africa and follow them for 12 months to see how surgery, tissue testing, and follow-up care work.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AIDS Malignancy Consortium Research network |
| Locations | 1 site (Kampala) |
| Trial ID | NCT04704648 on ClinicalTrials.gov |
What this trial studies
People living with HIV who have a single, non-invasive ocular surface squamous neoplasia (OSSN) lesion that an AMC-certified ophthalmologist deems resectable with 3 mm margins will undergo surgical excision. Lesions will be swabbed before surgery for HPV DNA testing in PrimeStore MTM and the excised tissue will be processed locally for histopathology and sent to Stellenbosch University for confirmatory testing. Participants will return for follow-up visits at 1 week, 6 weeks, 6 months, and 12 months to monitor healing, recurrence, and test results. The study will enroll up to 84 participants across multiple sites in sub‑Saharan Africa to determine feasibility of larger multi‑center prospective studies.
Who should consider this trial
Good fit: Ideal candidates are people living with HIV who have a single, suspected non‑invasive OSSN lesion that can be safely removed with 3 mm clinical margins while sparing the superior and inferior fornices and involving no more than 6 clock hours of the limbus.
Not a fit: Patients with invasive or unresectable tumors, lesions involving the excluded fornices or more than 6 clock hours of limbal involvement, HIV‑negative individuals, or those unable to attend scheduled follow‑up visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could help standardize surgical care and coordinated HPV/tissue testing for OSSN in people with HIV in sub‑Saharan Africa, improving diagnosis and follow‑up.
How similar studies have performed: Surgical excision is a well‑established treatment for OSSN and regional case series have reported good outcomes, but prospective multi‑center trials with standardized HPV testing in people living with HIV are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 3.2.1 Participants with suspected unilateral, non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices as well as 6 clock hours of the corneal scleral limbus. This assessment must be carried out within 4 weeks before surgery. 3.2.2 HIV positive. Documentation of HIV-1 infection by means of any one of the following: * Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Antiretroviral drug regimens used for pre-exposure prophylaxis (PrEP) may not satisfy this requirement.; * HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody/antigen combination assay; * Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA). WHO and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme or chemiluminescence assay (E/CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load. 3.2.3 Performance status ≤ 2 on the WHO Scale (see Appendix III). Exclusion Criteria: 3.3.1 Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted. 3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis. 3.3.3 Uncontrolled intercurrent illness within 4 weeks before enrollment, including but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Where this trial is running
Kampala
- Uganda Cancer Institute — Kampala, Uganda (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.