Trial Outcomes & Findings for The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients (NCT NCT01335230)

Last Updated: 2015-09-11

Results Overview

We measure gene transcription of the colon tissues (relative expression fold changes of gene transcription compared to control). No preselected criteria were used to assess the participants. Data were analyzed and compared among each group. Relative expression levels of LEAP-2 (Liver expressed anti-microbial peptide-2) in the four groups were shown in the table below. Detailed of other genes had been published in Shata MT, et al, J. Clin Pathology 2013, Nov 66(11):967-75. PMID 23940131, and Abdel-Hameed et al, J. Acquir Immune Defic Syndr. 2013 Jul 10 PMID: 23846566

Recruitment status

COMPLETED

Target enrollment

40 participants

Primary outcome timeframe

One year

Results posted on

2015-09-11

Participant Flow

We enrolled all the planned subjects (40) as suggested in our proposal within 15 months from University of Cincinnati outpatient clinic

We excluded patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases including rheumatoid arthritis, and any patients on systemic immunomodulators. Pregnant women were also excluded from the study.

Participant milestones

Participant milestones
Measure	10 HIV Mono-infected Subjects 10 subjects infected with HIV only	10 HCV Mono-infected Subjects 10 subjects infected with HCV only	10 HIV/HCV Co-infected Subjects 10 subjects infected with both HIV and HCV	10 Control Subjects 10 subjects without HIV, HCV, or both
Overall Study STARTED	10	10	10	10
Overall Study COMPLETED	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10 HIV Mono-infected Subjects n=10 Participants 10 subjects infected with HIV only	10 HCV Mono-infected Subjects n=10 Participants 10 subjects infected with HCV only	10 HIV/HCV Co-infected Subjects n=10 Participants 10 subjects infected with both HIV and HCV	10 Control Subjects n=10 Participants 10 subjects without HIV, HCV, or both	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	40 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	56.8 years STANDARD_DEVIATION 6.5 • n=7 Participants	49.1 years STANDARD_DEVIATION 6.2 • n=5 Participants	56 years STANDARD_DEVIATION 6.8 • n=4 Participants	51.4 years STANDARD_DEVIATION 9.3 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	40 participants n=21 Participants

PRIMARY outcome

Timeframe: One year

Population: All the samples were analyzed for gene array transcriptions and cytokines profiles

Outcome measures

Outcome measures
Measure	10 HIV Mono-infected Subjects n=10 Participants 10 subjects infected with HIV only	10 HCV Mono-infected Subjects n=10 Participants 10 subjects infected with HCV only	10 HIV/HCV Co-infected Subjects n=10 Participants 10 subjects infected with both HIV and HCV	10 Control Subjects n=10 Participants 10 subjects without HIV, HCV, or both
Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.	5.8 relative expression levels Standard Deviation 0.4	5.84 relative expression levels Standard Deviation 0.5	5.84 relative expression levels Standard Deviation 0.5	6.9 relative expression levels Standard Deviation 0.6

Adverse Events

10 HIV Mono-infected Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10 HCV Mono-infected Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10 HIV/HCV Co-infected Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10 Control Subjects

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

Mohamed Tarek M. shata

University of Cincinnati, Associate Prof., PI.

Phone: (513) 558-6110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place