CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Busulfan +2 moredrug
Likely dose
Not stated in 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/NCT01734850
NCT01734850Phase 2Completed
CompareCT.gov

An Adaptive Phase I/II Study of the Safety of CD4+ T Lymphocytes and CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, With and Without Conditioning With Busulfan in HIV-1 Infected Adults Previously Exposed to ART

Calimmune, Inc.·interventional·Posted Nov 28, 2012·Updated Aug 6, 2020

In Brief

A Phase 2 clinical trial evaluating Busulfan, Cal-1 modified HSPC, and 1 other intervention for Human Immunodeficiency Virus. Completed, enrolled 13 participants across 2 sites.

Detailed Summary

This is an early phase research study looking at whether an experimental gene transfer, LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the effects of HIV without the use of antiretroviral drugs. Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2 active parts: 1. Removing a protein named CCR5 from bone marrow and white blood cells 2. Producing a protein named C46 on bone marrow and white blood cells

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 28, 2012
Enrollment StartApr 1, 2013
Primary CompletionSep 1, 2017
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.6 years ago

Interventions

Busulfandrug

Intravenous busulfan

Cal-1 modified HSPCbiological

Hematopoietic progenitor/stem cells (HSPC) modified with LVsh5/C46 (Cal-1)

Cal-1 modified CD4+ T lymphocytesbiological

CD4+ T lymphocytes modified with LVsh5/C46 (Cal-1)