HIV And Parasitic Infection (HAPI) Study

• Status: Not yet recruiting
• Trial end date: 2023-05-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Fogarty International Center of the National Institute of Health
• Treatments: Albendazole; Antiparasitic Agents; Metronidazole; Praziquantel

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.