Trial Outcomes & Findings for HIV And Parasitic Infection (HAPI) Study (NCT NCT05323396)
NCT ID: NCT05323396
Last Updated: 2025-07-16
Results Overview
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".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Baseline
Results posted on
2025-07-16
Participant Flow
After signing informed consent, participants provide laboratory samples for evaluation of parasitic infection.
Participant milestones
| Measure |
Parasite-positive Arm
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool polymerase chain reaction (PCR) and Strongyloides IgG from plasma. If positive by either of these, the participant will be treated for the detected parasitic infection. The biomarker levels of this parasite-positive group will be compared to the parasite-negative group. Additionally the parasite-positive pre-treatment biomarker levels will be compared to the parasite-positive post-treatment levels.
Antiparasitic medication: Participants in the "parasite-positive" group (based on positive result of either stool microscopy, stool PCR, or Strongyloides IgG) will be administered antiparasitic treatment. Antiparasitic medication administered will be targeted to treat the parasite identified. See detailed description of protocol for medication, dose, and frequency that will be given for each parasitic infection identified.
Participants with stool microscopy, stool PCR, and Strongyloides IgG all negative will not be administered treatment, thus will serve as controls.
|
Parasite-negative Arm
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
84
|
|
Overall Study
Laboratory Evaluation Performed
|
36
|
84
|
|
Overall Study
Received Intervention
|
35
|
0
|
|
Overall Study
COMPLETED
|
34
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
35
|
Reasons for withdrawal
| Measure |
Parasite-positive Arm
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool polymerase chain reaction (PCR) and Strongyloides IgG from plasma. If positive by either of these, the participant will be treated for the detected parasitic infection. The biomarker levels of this parasite-positive group will be compared to the parasite-negative group. Additionally the parasite-positive pre-treatment biomarker levels will be compared to the parasite-positive post-treatment levels.
Antiparasitic medication: Participants in the "parasite-positive" group (based on positive result of either stool microscopy, stool PCR, or Strongyloides IgG) will be administered antiparasitic treatment. Antiparasitic medication administered will be targeted to treat the parasite identified. See detailed description of protocol for medication, dose, and frequency that will be given for each parasitic infection identified.
Participants with stool microscopy, stool PCR, and Strongyloides IgG all negative will not be administered treatment, thus will serve as controls.
|
Parasite-negative Arm
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
35
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
HIV And Parasitic Infection (HAPI) Study
Baseline characteristics by cohort
| Measure |
Parasite-positive Arm
n=36 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant will be treated for the detected parasitic infection. The biomarker levels of this parasite-positive group will be compared to the parasite-negative group. Additionally the parasite-positive pre-treatment biomarker levels will be compared to the parasite-positive post-treatment levels.
Antiparasitic medication: Participants in the "parasite-positive" group (based on positive result of either stool microscopy, stool PCR, or Strongyloides IgG) will be administered antiparasitic treatment. Antiparasitic medication administered will be targeted to treat the parasite identified. See detailed description of protocol for medication, dose, and frequency that will be given for each parasitic infection identified.
Participants with stool microscopy, stool PCR, and Strongyloides IgG all negative will not be administered treatment, thus will serve as controls.
|
Parasite-negative Arm
n=84 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
44 years
n=7 Participants
|
43.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Malawi
|
36 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe 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".
Outcome measures
| Measure |
Parasite-negative Arm
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=120 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Number of Participants With and Without Intestinal Parasitic Infection
Parasite-positive
|
—
|
36 Participants
|
|
Number of Participants With and Without Intestinal Parasitic Infection
Parasite-negative
|
—
|
84 Participants
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Parasite-negative Arm
n=84 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=36 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Mean Soluble CD14 (sCD14) Levels
|
1.52 µg/mL
Standard Deviation 0.42
|
1.42 µg/mL
Standard Deviation 0.39
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Parasite-negative Arm
n=84 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=36 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Mean Soluble CD163 (sCD163) Levels
|
744.61 ng/mL
Standard Deviation 218.06
|
736.13 ng/mL
Standard Deviation 212.63
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Parasite-negative Arm
n=84 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=36 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Mean Intestinal Fatty-acid Binding Protein (I-FABP) Levels
|
3.49 ng/mL
Standard Deviation 2.62
|
3.33 ng/mL
Standard Deviation 3.22
|
PRIMARY outcome
Timeframe: Baseline, 6 months after baseline visitThe 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.
Outcome measures
| Measure |
Parasite-negative Arm
n=49 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=34 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Percent Change of sCD14 Levels Pre- and Post-treatment
|
-0.90 percent change
Standard Deviation 24.36
|
8.52 percent change
Standard Deviation 30.41
|
PRIMARY outcome
Timeframe: Baseline, 6 months after baseline visitThe 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.
Outcome measures
| Measure |
Parasite-negative Arm
n=49 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=34 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Percent Change of sCD163 Levels Pre- and Post-treatment
|
-8.56 percent change
Standard Deviation 24.71
|
-7.38 percent change
Standard Deviation 15.18
|
PRIMARY outcome
Timeframe: Baseline, 6 months after baseline visitThe 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.
Outcome measures
| Measure |
Parasite-negative Arm
n=49 Participants
Participants will be evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If negative by all of these tests on the initial sample collection, the participants will not receive treatment and will be in the "parasite-negative"/no intervention arm.
|
Participants With and Without Parasitic Infection
n=34 Participants
Participants evaluated for intestinal parasitic infection by stool microscopy, stool PCR and Strongyloides IgG from plasma. If positive by either of these, the participant was treated for the detected parasitic infection.
|
|---|---|---|
|
Percent Change of I-FABP Levels Pre- and Post-treatment
|
107.31 percent change
Standard Deviation 278.19
|
79.85 percent change
Standard Deviation 268.28
|
Adverse Events
Parasite-positive Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parasite-negative Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melisa Reimer-McAtee, MD
University of North Carolina at Chapel Hill
Phone: 265 175 5056
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place