Trial Outcomes & Findings for Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy (NCT NCT00661960)

NCT ID: NCT00661960

Last Updated: 2017-05-30

Results Overview

Duodenal tissue immune cell subsets were measured by flow cytometry.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: nine months
• Results posted on: 2017-05-30

Participant Flow

Subjects are recruited from the specialty clinic and their friends or family.

no special pre-assignment details

Participant milestones

Measure	Negative Volunteers HIV Negative volunteers	HIV-postive Randomized to Raltegravir HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications	HIV-postive Randomized to NNRTI HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
Overall Study STARTED	5	10	10
Overall Study COMPLETED	5	7	9
Overall Study NOT COMPLETED	0	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

Baseline characteristics by cohort

Measure	Negative Volunteers n=5 Participants HIV Negative volunteers	HIV-postive Randomized to Raltegravir n=10 Participants HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications	HIV-postive Randomized to NNRTI n=10 Participants HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications	Total n=25 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
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	25 Participants n=4 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
Age, Continuous	35 years STANDARD_DEVIATION 5 • n=5 Participants	37 years STANDARD_DEVIATION 5 • n=7 Participants	45 years STANDARD_DEVIATION 5 • n=5 Participants	38 years STANDARD_DEVIATION 5 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	25 participants n=4 Participants

PRIMARY outcome

Timeframe: nine months

Population: all subjects who completed all study visits

Duodenal tissue immune cell subsets were measured by flow cytometry.

Outcome measures

Measure	Negative Volunteers n=5 Participants HIV Negative volunteers	HIV-postive Randomized to Raltegravir n=7 Participants HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications	HIV-postive Randomized to NNRTI n=9 Participants HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.	55.3 % CD3/CD4 T-cells in GALT tissue Interval 42.0 to 67.0	11.7 % CD3/CD4 T-cells in GALT tissue Interval 9.1 to 22.3	9.9 % CD3/CD4 T-cells in GALT tissue Interval 8.7 to 18.2

Adverse Events

Negative Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-postive Randomized to Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV-postive Randomized to NNRTI

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

David Asmuth/Principal Investigator

UCaliforniaDavis

Phone: 9167348695

Email: david.asmuth@ucdmc.ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place