CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Ixazomib 1 MG +3 moredrug
Likely dose
Ixazomib 1 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02946047
NCT02946047Phase 2Completed

Pilot Study of Ixazomib to Reduce the Number of HIV DNA Positive Lymphoid Cells

Mayo Clinic·interventional·Posted Oct 26, 2016·Updated Jan 6, 2022

In Brief

A Phase 2 clinical trial evaluating Ixazomib 1 MG, Ixazomib 2 MG, and 2 other interventions for Human Immunodeficiency Virus (HIV). Completed, enrolled 17 participants across 1 site.

Detailed Summary

The primary purpose of the trial is to determine the safety and tolerability of ixazomib in HIV infected patients on antiretroviral therapy. The secondary purpose is to determine the effect of ixazomib on the size of the HIV reservoir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 26, 2016
Enrollment StartMar 20, 2017
Primary CompletionAug 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.7 years ago

Interventions

Ixazomib 1 MGdrug

1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Ixazomib 2 MGdrug

2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Ixazomib 3 MGdrug

3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.

Ixazomib 4 MGdrug

4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.