HIV Coinfection Clinical Trial
— HAPIOfficial title:
Impact of Parasitic Infections on Intestinal Epithelial Barrier and Immune Activation Among Persons Living With HIV in Lilongwe, Malawi
Verified date | January 2024 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | August 4, 2023 |
Est. primary completion date | August 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Malawi | Lighthouse Clinic | Lilongwe |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Fogarty International Center of the National Institute of Health |
Malawi,
Cheru LT, Park EA, Saylor CF, Burdo TH, Fitch KV, Looby S, Weiner J, Robinson JA, Hubbard J, Torriani M, Lo J. I-FABP Is Higher in People With Chronic HIV Than Elite Controllers, Related to Sugar and Fatty Acid Intake and Inversely Related to Body Fat in People With HIV. Open Forum Infect Dis. 2018 Nov 5;5(11):ofy288. doi: 10.1093/ofid/ofy288. eCollection 2018 Nov. — View Citation
Knudsen TB, Ertner G, Petersen J, Moller HJ, Moestrup SK, Eugen-Olsen J, Kronborg G, Benfield T. Plasma Soluble CD163 Level Independently Predicts All-Cause Mortality in HIV-1-Infected Individuals. J Infect Dis. 2016 Oct 15;214(8):1198-204. doi: 10.1093/infdis/jiw263. Epub 2016 Jun 28. — View Citation
Sandler NG, Wand H, Roque A, Law M, Nason MC, Nixon DE, Pedersen C, Ruxrungtham K, Lewin SR, Emery S, Neaton JD, Brenchley JM, Deeks SG, Sereti I, Douek DC; INSIGHT SMART Study Group. Plasma levels of soluble CD14 independently predict mortality in HIV infection. J Infect Dis. 2011 Mar 15;203(6):780-90. doi: 10.1093/infdis/jiq118. Epub 2011 Jan 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of participants with intestinal parasitic infection | The prevalence of participants with intestinal parasitic infection will be determined based on the number of parasite-positive participants divided by the total number of participants. | Baseline | |
Primary | Mean soluble CD14 (sCD14) levels | The level of sCD14 detected in plasma will be measured in all patients at the baseline visit. The mean level of sCD14 of the parasite-positive group will be compared to the mean level of sCD14 of the parasite-negative group (pg/mL) using Student's unpaired t-test. | Baseline | |
Primary | Mean soluble CD163 (sCD163) levels | The level of sCD163 detected in plasma will be measured in all patients at the baseline visit. The mean level of sCD163 of the parasite-positive group will be compared to the mean level of sCD163 of the parasite-negative group (mg/L) using Student's unpaired t-test. | Baseline | |
Primary | Mean Intestinal Fatty-acid Binding Protein (I-FABP) levels | The level of I-FABP detected in plasma will be measured in all patients at the baseline visit. The mean level of I-FABP of the parasite-positive group will be compared to the mean level of I-FABP of the parasite-negative group (pg/mL) using Student's unpaired t-test. | Baseline | |
Primary | Change in sCD14 levels pre- and post-treatment | The level of sCD14 detected in plasma will be measured in all patients at the initial visit and the follow-up visit (pg/mL). The change in sCD14 pre-treatment and post-treatment levels of the parasite-positive group will be compared to the change in sCD14 pre- and post-treatment levels of the parasite-negative participants. | Baseline, 6 months after baseline visit | |
Primary | Change in sCD163 levels pre- and post-treatment | The level of sCD163 detected in plasma will be measured in all patients at the initial visit and the follow-up visit (mg/L). The change in sCD163 pre-treatment and post-treatment levels of the parasite-positive group will be compared to the change in sCD163 pre- and post-treatment levels of the parasite-negative participants. | Baseline, 6 months after baseline visit | |
Primary | Change in I-FABP levels pre- and post-treatment | The level of I-FABP detected in plasma will be measured in all patients at the initial visit and the follow-up visit (pg/mL). The change in I-FABP pre-treatment and post-treatment levels of the parasite-positive group will be compared to the change in I-FABP pre- and post-treatment levels of the parasite-negative participants. | Baseline, 6 months after baseline visit |
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