Impact of Parasitic Infections on Intestinal Epithelial Barrier and Immune Activation Among Persons Living With HIV in Lilongwe, Malawi

21-2553

The overall goal of this study is to determine if periodic de-worming of persons living with HIV in intestinal parasite-endemic regions will lead to decreased morbidity and mortality associated with HIV by reducing immune activation and intestinal damage associated with these diseases. The hypothesis for this project is that intestinal parasitic infections contribute to a modifiable pro-inflammatory state in persons living with HIV (PLWH). Aim 1: Determine the prevalence of intestinal parasitic infections in PLWH receiving care at an HIV-treatment center in Lilongwe, Malawi using a highly sensitive multi-parallel stool PCR test. Hypothesis: highly sensitive stool PCR testing will demonstrate that disease burden of parasitic infection in PLWH in Malawi is higher than historically reported based on stool microscopy. Aim 2: Determine the impact of parasitic infection on intestinal damage and immune activation by measuring sCD14, sCD163, and intestinal fatty acid binding protein (I-FABP) in PLWH. Hypothesis: plasma biomarkers reflecting intestinal damage and immune activation are elevated in those with HIV and parasitic co-infection compared with parasite-negative participants with HIV. Aim 3: Determine the impact of eradication of parasitic infection on intestinal damage and immune activation by measuring sCD14, sCD163, and intestinal fatty acid binding protein (I-FABP) in PLWH before and after treatment of parasitic co-infection. Hypothesis: plasma biomarkers reflecting intestinal damage and immune activation are elevated in those with HIV and parasitic co-infection, and these biomarkers decrease with anti-parasitic treatment.

2022-05-02

2023-08-04

2023-08-04

Completed

120

Inclusion Criteria: * Age ≥ 18 years * currently living in Malawi * HIV-1 infection * on ART ≥ 1 year with undetectable HIV RNA level at the last evaluation * willingness to be treated with anti-parasitic therapy if infection with intestinal parasite is identified. Exclusion Criteria: * Use of antibiotics other than prophylaxis with trimethoprim-sulfamethoxazole within 60 days of screening * Use of antiparasitic medication (ex- albendazole, praziquantel, metronidazole) in the last year * Inflammatory bowel disease * Gastrointestinal tract malignancy * Major intestinal surgery during prior 2 years * Coinfection with Mycobacterium tuberculosis * Pregnancy, breastfeeding mother, or planning pregnancy.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial is closest to a parallel trial, but different from most clincial trials in that the participants will not be randomized by the study team. The two groups will be determined based on the results of the initial sample collection. Those with a result positive for intestinal parasitic infection (by either stool microscopy, stool PCR, or Strongyloides IgG) will be in the "parasite-positive" group for the remainder of the study. Those negative for all of these will be in the "parasite-negative" group. The markers sCD14, sCD163, and I-FABP will be compared between the two groups. Additionally a comparison will be made between the pre-treatment and post-treatment levels of the "parasite-positive" participants.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The participants and the study team will know the results of the tests, and thus will know the groups that the participants are in, since only the "parasite-positive" participants will receive treatment.'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

2024-02-01