N/A
Completed N=120
HIV And Parasitic Infection (HAPI) Study
HIV Coinfection
Source: ClinicalTrials.gov NCT05323396 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants With and Without Intestinal Parasitic Infection — 36; 84 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With and Without Intestinal Parasitic Infection |
36; 84 | — |
| PRIMARY Mean Soluble CD14 (sCD14) Levels |
1.42; 1.52 | 0.19 |
| PRIMARY Mean Soluble CD163 (sCD163) Levels |
736.13; 744.61 | 0.85 |
| PRIMARY Mean Intestinal Fatty-acid Binding Protein (I-FABP) Levels |
3.33; 3.49 | 0.77 |
| PRIMARY Percent Change of sCD14 Levels Pre- and Post-treatment |
8.52; -0.90 | 0.12 |
| PRIMARY Percent Change of sCD163 Levels Pre- and Post-treatment |
-7.38; -8.56 | 0.81 |
| PRIMARY Percent Change of I-FABP Levels Pre- and Post-treatment |
79.85; 107.31 | 0.65 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05323396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.