Trial · NCT05323396

HIV And Parasitic Infection (HAPI) Study

NCT05323396, Not applicable, Completed, University of North Carolina, Chapel Hill; results first posted 2024-07-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HIV And Parasitic Infection (HAPI) Study. Trials, record NCT05323396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05323396

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HIV And Parasitic Infection (HAPI) Study
NCT number: NCT05323396
Status: Completed
Phases: Not applicable
Enrollment: 120 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: HIV Coinfection
Interventions: Antiparasitic medication
First posted: 2022-04-12
Last updated: 2025-07-16
Results first posted: 2024-07-16

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With and Without Intestinal Parasitic Infection	Baseline	The number of participants with and without parasitic infection was determined based on diagnostic tests utilized. Participants with a positive result by either stool microscopy or stool PCR were considered "parasite-positive". Participants negative by both diagnostic tests were considered "parasite-negative".
Primary	Mean Soluble CD14 (sCD14) Levels	Baseline	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 (µg/mL) using Student's unpaired t-test.
Primary	Mean Soluble CD163 (sCD163) Levels	Baseline	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 (ng/mL) using Student's unpaired t-test.
Primary	Mean Intestinal Fatty-acid Binding Protein (I-FABP) Levels	Baseline	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 (ng/mL) using Student's unpaired t-test.
Primary	Percent Change of sCD14 Levels Pre- and Post-treatment	Baseline, 6 months after baseline visit	The level of sCD14 detected in plasma will be measured in all patients at the initial visit and the follow-up visit (µg/mL). The percent change of sCD14 from pre-treatment to post-treatment levels of the parasite-positive group will be compared to the percent change of sCD14 from pre- to post-treatment levels of the parasite-negative participants.
Primary	Percent Change of sCD163 Levels Pre- and Post-treatment	Baseline, 6 months after baseline visit	The level of sCD163 detected in plasma will be measured in all patients at the initial visit and the follow-up visit (ng/mL). The percent change of sCD163 from pre-treatment to post-treatment levels of the parasite-positive group will be compared to the percent change of sCD163 from pre- to post-treatment levels of the parasite-negative participants.
Primary	Percent Change of I-FABP Levels Pre- and Post-treatment	Baseline, 6 months after baseline visit	The level of I-FABP detected in plasma will be measured in all patients at the initial visit and the follow-up visit (ng/mL). The percent change of I-FABP levels from pre-treatment to post-treatment of the parasite-positive group will be compared to the percent change of I-FABP levels pre- and post-treatment of the parasite-negative participants.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With and Without Intestinal Parasitic Infection	Baseline	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Mean Soluble CD14 (sCD14) Levels	Baseline	µg/mL	MEAN
PRIMARY	Mean Soluble CD163 (sCD163) Levels	Baseline	ng/mL	MEAN
PRIMARY	Mean Intestinal Fatty-acid Binding Protein (I-FABP) Levels	Baseline	ng/mL	MEAN
PRIMARY	Percent Change of sCD14 Levels Pre- and Post-treatment	Baseline, 6 months after baseline visit	percent change	MEAN
PRIMARY	Percent Change of sCD163 Levels Pre- and Post-treatment	Baseline, 6 months after baseline visit	percent change	MEAN
PRIMARY	Percent Change of I-FABP Levels Pre- and Post-treatment	Baseline, 6 months after baseline visit	percent change	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With and Without Intestinal Parasitic Infection	Participants With and Without Parasitic Infection	Parasite-positive	36		Participants
Number of Participants With and Without Intestinal Parasitic Infection	Participants With and Without Parasitic Infection	Parasite-negative	84		Participants
Mean Soluble CD14 (sCD14) Levels	Parasite-positive Arm		1.42	Standard Deviation 0.39	µg/mL
Mean Soluble CD14 (sCD14) Levels	Parasite-negative Arm		1.52	Standard Deviation 0.42	µg/mL
Mean Soluble CD163 (sCD163) Levels	Parasite-positive Arm		736.13	Standard Deviation 212.63	ng/mL
Mean Soluble CD163 (sCD163) Levels	Parasite-negative Arm		744.61	Standard Deviation 218.06	ng/mL
Mean Intestinal Fatty-acid Binding Protein (I-FABP) Levels	Parasite-positive Arm		3.33	Standard Deviation 3.22	ng/mL
Mean Intestinal Fatty-acid Binding Protein (I-FABP) Levels	Parasite-negative Arm		3.49	Standard Deviation 2.62	ng/mL
Percent Change of sCD14 Levels Pre- and Post-treatment	Parasite-positive Arm		8.52	Standard Deviation 30.41	percent change
Percent Change of sCD14 Levels Pre- and Post-treatment	Parasite-negative Arm		-0.90	Standard Deviation 24.36	percent change

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Parasite-positive Arm	36
Overall Study	STARTED	Parasite-negative Arm	84
Overall Study	Laboratory Evaluation Performed	Parasite-positive Arm	36
Overall Study	Laboratory Evaluation Performed	Parasite-negative Arm	84
Overall Study	Received Intervention	Parasite-positive Arm	35
Overall Study	Received Intervention	Parasite-negative Arm	0
Overall Study	COMPLETED	Parasite-positive Arm	34
Overall Study	COMPLETED	Parasite-negative Arm	49
Overall Study	NOT COMPLETED	Parasite-positive Arm	2
Overall Study	NOT COMPLETED	Parasite-negative Arm	35

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Parasite-positive Arm	36
Total, all-cause mortality	Parasite-negative Arm	0
Total, other adverse events	Parasite-positive Arm	36
Total, other adverse events	Parasite-negative Arm	0
Total, serious adverse events	Parasite-positive Arm	36
Total, serious adverse events	Parasite-negative Arm	0

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21252259	BACKGROUND	PubMed
27354366	BACKGROUND	PubMed
30515430	BACKGROUND	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
D43TW009340	UJMT LAUNCH: Training the next generation of leaders in global health research	CHI, BENJAMIN H.; CHECKLEY, WILLIAM; KONDWANI, KOFI A; MOON, D. TROY	UNIV OF NORTH CAROLINA CHAPEL HILL	FOGARTY INTERNATIONAL CENTER	2017 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05323396

GET https://conductscience.org/api/trials/v1/NCT05323396/registered

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