Trial Outcomes & Findings for Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut (NCT NCT00884793)

NCT ID: NCT00884793

Last Updated: 2012-07-23

Results Overview

Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2012-07-23

Participant Flow

Participant milestones

Measure	Intensification Arm In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Intensification Arm In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut

Baseline characteristics by cohort

Measure	Intensification Arm n=8 Participants In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	48.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: We analyzed data from all subjects who had endosocopies at week 12.

Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum

Outcome measures

Measure	Intensification Arm n=7 Participants 5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum	5 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Includes all with gut samples from week 12.

Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12.

Outcome measures

Measure	Intensification Arm n=7 Participants 5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.	6 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Includes all those who had endoscopy at week 12

Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum

Outcome measures

Measure	Intensification Arm n=7 Participants 5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
Number of Subjects Who Experienced an Increase in CD4% in the Ileum.	5 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All patients who had endoscopy at week 12.

Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry

Outcome measures

Measure	Intensification Arm n=7 Participants 5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
Average Change in "Activated" (CD38+HLADR+) CD8+ T Cells in the Ileum	-5.4 percentage change Standard Error 4.5

Adverse Events

Intensification 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

Steven Yukl

UCSF

Phone: 415-221-4810

Email: steven.yukl@ucsf.edu

Results disclosure agreements

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