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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00074997




Registration number
NCT00074997
Ethics application status
Date submitted
28/12/2003
Date registered
31/12/2003
Date last updated
20/06/2016

Titles & IDs
Public title
An Efficacy and Safety Study of Autologous Cluster of Differentiation 34 (CD34+) Hematopoietic Progenitor Cells Transduced With Placebo or an Anti- Human Immunodeficiency Virus Type 1 (HIV-1) Ribozyme (OZ1) in Participants With HIV-1 Infection
Scientific title
A Randomized Phase II, Double-Blind, Controlled Trial to Evaluate the Safety and Efficacy of Autologous CD34+ Hematopoietic Progenitor Cells Transduced With Placebo or an Anti-HIV-1 Ribozyme (OZ1) in Patients With HIV-1 Infection
Secondary ID [1] 0 0
OZ1-HV1-201
Secondary ID [2] 0 0
CR010783
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - OZ1
Other interventions - CD34+ cells

Experimental: 001 - OZ1 Single intravenous infusion of 2-20 x 10 to the power of 7 OZ1 transduced autologous CD34+ cells per kilogram of body weight

Placebo Comparator: 002 - Placebo Single intravenous infusion of placebo transduced autologous CD34+ cells per kilogram of body weight


Other interventions: Placebo
Single intravenous infusion of placebo.

Other interventions: OZ1
Single intravenous infusion of OZ1.

Other interventions: CD34+ cells
Autologous CD34+ cells.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in viral load between the placebo and OZ1 groups.
Timepoint [1] 0 0
Week 47
Primary outcome [2] 0 0
Difference in viral load between the placebo and OZ1 groups.
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
CD4+ cell count
Timepoint [1] 0 0
Weeks 41 - 48
Secondary outcome [2] 0 0
HIV proviral DNA
Timepoint [2] 0 0
Weeks 41 - 48
Secondary outcome [3] 0 0
Thymic function
Timepoint [3] 0 0
Weeks 41 - 48
Secondary outcome [4] 0 0
Time to resumption of antiretroviral therapy
Timepoint [4] 0 0
Weeks 41 - 48

Eligibility
Key inclusion criteria
- An Human Immunodeficiency Virus 1 (HIV-1) infection for at least 6 months documented
by positive HIV serology including confirmation by Western Blot

- Receiving either the first or second regimen of antiretroviral therapy (ART) defined
as 3 or more antiretroviral drugs in combination

- A Viral load less than 400 copies per milliliter (copies/ml), as measured by Roche
Amplicor HIV-1 Monitor assay, on 2 consecutive occasions, at least 7 days apart and
within 45 days prior to granulocyte colony-stimulating factor (G-CSF) administration
and the second measurement has to be within 14 days prior to G-CSF

- Cluster of Differentiation 4 (CD4+) cell count must be greater that 300 cells per
cubic millimeter (cells/mm^3)

- Women and men (or their partners) had to agree to use a medically accepted form of
contraception and safe sexual practices
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any previous or current Acquired Immunodeficiency Syndrome (AIDS) defining illness by
the Center for Disease Control (CDC) case definition, including AIDS-related dementia
(mental decline), with the exception of Kaposi's sarcoma (purple or brown cancerous
pimples on the skin, often associated with AIDS)

- Clinically significant clinical laboratory results

- Participants with veins unsuitable for study related procedures

- Current ART that included antiretroviral agents which exhibited antagonism when used
together (example, zidovudine and stavudine ), or current or previous ART that
included hydroxyurea

- Current pregnancy or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and efficacy of administration of a
cell-delivered ribozyme gene transfer product to participants with chronic (lasting a long
time) Human Immunodeficiency Virus Type 1 (HIV-1) infection (a life-threatening infection
which you can get from an infected person's blood or from having sex with an infected
person).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00074997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00074997