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Surgical removal of eye surface tumors in people living with HIV in Africa

Tests surgical removal of suspected eye surface tumors in adults living with HIV.

Plain-language title generated from the registry record
Registry title: Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa

Key facts

Where
Kampala, UgandaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with HIV who have a suspected growth on the surface of one eye that can be removed by surgery.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Suspected non-invasive ocular surface squamous neoplasia (OSSN) in one eye only. The eye doctor must judge that it can be cut out with 3 mm clinical margins, sparing the upper and lower fornices and 6 clock hours of the limbus (edge of the cornea). This is assessed within 4 weeks before surgery.
Earlier treatment
No other investigational agents within 30 days before enrollment for surgery. Investigational ART regimens are allowed.
Biomarker or test result
HIV-1 infection must be documented: proof of ART, or a licensed HIV-1 RNA test showing more than 1000 copies/mL, or a licensed HIV screening test confirmed by a second licensed test. Performance status of 2 or lower on the WHO scale.

Main reasons for not taking part

  • Known history of ocular surface lesions, including OSSN, other eye tumours, pterygia, or limbal vernal keratoconjunctivitis
  • Uncontrolled illness within 4 weeks before enrollment, such as an active infection
  • Psychiatric illness or social situations that would limit following the study requirements
  • Other investigational agents within 30 days before enrollment, except investigational ART

This trial only enrols participants living with HIV. The registry sentence this rests on: 3.2.2 HIV positive. Documentation of HIV-1 infection by means of any one of the following:

Read by machine on 12 November 2026.

Where in Uganda

  • Uganda Cancer InstituteKampala, UgandaContact: Anne Ampaire Musika, MMed, MSCTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
AIDS Malignancy Consortium
Trial code
NCT04704648
Record updated
23 March 2026
Original description
Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV/AIDS (PLWHA). Participants include those with HIV infection and with suspected 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 and 6 clock hours of the corneal scleral limbus.Read full original descriptionShow less

Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)

Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV/AIDS (PLWHA). Participants include those with HIV infection and with suspected 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 and 6 clock hours of the corneal scleral limbus.

Inclusion: 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: 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; 3.3.3 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; 3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.

ClinicalTrials.gov NCT04704648