HIV-1 InfectionNCT02390297
Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients
An observational study of HIV-1 Infection and Receipt of Cal-1 Modified Hematopoietic Cellular Products, run by Calimmune, Inc. at 2 sites in United States.
Trial summary
Long term safety follow-up of Cal-1 recipients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV-1 Infection, Receipt of Cal-1 Modified Hematopoietic Cellular Products
- What is being tested?
- Blood tests
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligibility for this protocol is dependent on prior exposure to a Cal-1 modified hematopoietic cellular product. The study population will thus consist of individuals with HIV-1 infection, who have met criteria for participation in a Cal-1 phase I/II clinical trial and received a dose of Cal-1 modified hematopoietic cells as part of a previous study
Who may be able to join
- Signed informed consent
- Previous treatment with the Cal-1 modified hematopoietic cellular products
Who cannot join
- Inability to understand and provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCLA CARE Center
Los Angeles, California, 90035
Quest Clinical Research
San Francisco, California, 94115
About this study
Official title: Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
Long term safety follow-up of Cal-1 recipients
Read the detailed description
Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct
- Being tested
- Blood tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsGenetic
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses
| Study group | Role | What they receive |
|---|---|---|
| Single | Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses Receives: Genetic: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures
Measured: 15 years
Secondary outcomes (1)
Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood
Measured: 15 yars
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raphael Landovitz, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390297
- Sponsor's protocol ID
- CAL-INT-00
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2015
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
- ClinicalTrials.gov ID
- NCT02390297
- Acronym / sponsor ID
- CAL-INT-00
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Calimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term safety follow-up of Cal-1 recipients
Detailed description
Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | – | Genetic: Blood testsCollection of blood samples for general health (complete blood count) and Cal-1 specific analyses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligibility for this protocol is dependent on prior exposure to a Cal-1 modified hematopoietic cellular product. The study population will thus consist of individuals with HIV-1 infection, who have met criteria for participation in a Cal-1 phase I/II clinical trial and received a dose of Cal-1 modified hematopoietic cells as part of a previous study
Key inclusion criteria (2 listed)
- Signed informed consent
- Previous treatment with the Cal-1 modified hematopoietic cellular products
Key exclusion criteria (1 listed)
- Inability to understand and provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testsCollection of blood samples for general health (complete blood count) and Cal-1 specific analyses | Genetic | Single |
Primary outcome
Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures
Time frame: 15 years
1 secondary outcome
Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood
Time frame: 15 yars
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Landovitz, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 Infection and Receipt of Cal-1 Modified Hematopoietic Cellular Products, run by Calimmune, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.