HIV InfectionsEarly Phase 1NCT06117657
Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects
A Early Phase 1 study testing Low dose KL-HIV-Tri01, Middle dose KL-HIV-Tri01 and High dose KL-HIV-Tri01 in people with HIV Infections, run by Affiliated Hospital of Guangdong Medical University.
Trial summary
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Low dose KL-HIV-Tri01, Middle dose KL-HIV-Tri01 and High dose KL-HIV-Tri01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2023to 10 Sep 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 (not inclusive) to 80 (inclusive) years of age, both male and female.
- 2. Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
- 3. CD4+T cell count≥500 cells/μl.
- 4. On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
- 5. Willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form.
Who cannot join
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.
- Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.
- Currently treated with Immunosuppressive medications or steroids.
- Previous receipt of HIV vaccine, antibody or gene therapy.
Trial locations and contacts
No sites are listed yet.
About this study
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART.
Read the detailed description
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution expressing triple targets antibodies with broad HIV-1 neutralizing activity in HIV-1 infected adults on anti-retroviral therapy (ARV). Nine subjects will be enrolled and administered with three different doses of KL-HIV-Tri01. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL-HIV-Tri01. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL-HIV-Tri01 for total 5 years.
- Conditions
- HIV Infections
- Being tested
- Low dose KL-HIV-Tri01, Middle dose KL-HIV-Tri01, High dose KL-HIV-Tri01
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose KL-HIV-Tri01Drug
Also called rAAV vector
Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^11 vg/kg.
Middle dose KL-HIV-Tri01Drug
Also called rAAV vector
Subjects will be dosed with single dose of KL-HIV-Tri01 at 8.0x10^11 vg/kg.
High dose KL-HIV-Tri01Drug
Also called rAAV vector
Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^12 vg/kg.
| Study group | Role | What they receive |
|---|---|---|
| KL-HIV-Tri01 injection solution | Experimental | Subjects will be dosed with three different dose of KL-HIV-Tri01 injection solution at 2.4x10^11 vg/kg to 2.4x10^12 vg/kg. Receives: Drug: Low dose KL-HIV-Tri01; Drug: Middle dose KL-HIV-Tri01; Drug: High dose KL-HIV-Tri01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of AEs and SAEs
AEs and SAEs from the date of product administration will be recorded through the last study visit. The relationship between AEs and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol.
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Neutralizing Antibodies Against KL-HIV-Tri01 Capsid
Anti-KL-HIV-Tri01 Capsid antibodies were analyzed by enzyme-linked immunosorbent assay (ELISA) using a vector-matched AAV capsid as the capture agent.
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Inhibitors of broadly neutralizing antibodies
Inhibitors against broadly neutralizing antibodies expressed by KL-HIV-Tri01 were analyzed by enzyme-linked immunosorbent assay (ELISA) .
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Cells mediated immune response against capsids and bNabs
Number of participants with T-cell response to AAV capsid and transgene products was planned to be reported.
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Secondary outcomes (4)
Concentration and titer of serum neutralizing antibodies
The serum concentration and titer of neutralizing antibodies produced by KL-HIV-Tri01 at specified time intervals for 52 weeks after dosing was determined
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
CD4+T, CD8+T cell count
The clinical effects of KL-HIV-Tri01 on CD4+T and CD8+T cell count were assessed. CD4+T and CD8+T Cell Count (cells/mL) shown as reported by the Clinical Center serology lab
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
viral load
The clinical effects of KL-HIV-Tri01 on viral load were assessed after interruption of HAART.
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Time to interrupt HAART treatment
The duration of anti-HIV replication effection of the neutralizing antibodies produced by KL-HIV-Tri01were assessed after interruption of HAART.
Measured: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start10 Nov 2023 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Low dose group will be administrated with 2.4×10\^11 vg/kg; Middle dose group will be administrated with 8.0×10\^11 vg/kg; High dose group will be administrated with 2.4×10\^12 vg/kg;
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Guangdong Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Honghua He, Affiliated Hospital of Guangdong Medical University
- Investigators
- Honghua He, MD, Principal investigator, Affiliated Hospital of Guangdong Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117657
- Sponsor's protocol ID
- CP-Tri01-001/01
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects
- ClinicalTrials.gov ID
- NCT06117657
- Acronym / sponsor ID
- CP-Tri01-001/01
- Conditions
- HIV Infections
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Guangdong Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- 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.
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART.
Detailed description
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution expressing triple targets antibodies with broad HIV-1 neutralizing activity in HIV-1 infected adults on anti-retroviral therapy (ARV). Nine subjects will be enrolled and administered with three different doses of KL-HIV-Tri01. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL-HIV-Tri01. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL-HIV-Tri01 for total 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low dose group will be administrated with 2.4×10^11 vg/kg; Middle dose group will be administrated with 8.0×10^11 vg/kg; High dose group will be administrated with 2.4×10^12 vg/kg;
| Arm | Type | Receives |
|---|---|---|
| KL-HIV-Tri01 injection solution | Experimental | Drug: Low dose KL-HIV-Tri01, Drug: Middle dose KL-HIV-Tri01, Drug: High dose KL-HIV-Tri01Subjects will be dosed with three different dose of KL-HIV-Tri01 injection solution at 2.4x10^11 vg/kg to 2.4x10^12 vg/kg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.18 (not inclusive) to 80 (inclusive) years of age, both male and female.
- 2. Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
- 3. CD4+T cell count≥500 cells/μl.
- 4. On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
- 5. Willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form.
Key exclusion criteria (5 listed)
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.
- Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.
- Currently treated with Immunosuppressive medications or steroids.
- Previous receipt of HIV vaccine, antibody or gene therapy.
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 |
|---|---|---|
| Low dose KL-HIV-Tri01Also: rAAV vectorSubjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^11 vg/kg. | Drug | KL-HIV-Tri01 injection solution |
| Middle dose KL-HIV-Tri01Also: rAAV vectorSubjects will be dosed with single dose of KL-HIV-Tri01 at 8.0x10^11 vg/kg. | Drug | KL-HIV-Tri01 injection solution |
| High dose KL-HIV-Tri01Also: rAAV vectorSubjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^12 vg/kg. | Drug | KL-HIV-Tri01 injection solution |
Primary outcome
Number and severity of AEs and SAEs
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
AEs and SAEs from the date of product administration will be recorded through the last study visit. The relationship between AEs and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol.
Neutralizing Antibodies Against KL-HIV-Tri01 Capsid
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Anti-KL-HIV-Tri01 Capsid antibodies were analyzed by enzyme-linked immunosorbent assay (ELISA) using a vector-matched AAV capsid as the capture agent.
Inhibitors of broadly neutralizing antibodies
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Inhibitors against broadly neutralizing antibodies expressed by KL-HIV-Tri01 were analyzed by enzyme-linked immunosorbent assay (ELISA) .
Cells mediated immune response against capsids and bNabs
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Number of participants with T-cell response to AAV capsid and transgene products was planned to be reported.
4 secondary outcomes
Concentration and titer of serum neutralizing antibodies
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
CD4+T, CD8+T cell count
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
viral load
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Time to interrupt HAART treatment
Time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Honghua He, MD principal investigator
Affiliated Hospital of Guangdong Medical University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low dose KL-HIV-Tri01, Middle dose KL-HIV-Tri01 and High dose KL-HIV-Tri01 in people with HIV Infections, run by Affiliated Hospital of Guangdong Medical University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honghua He, MD (+86 138 2822 9695, 192880@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of AEs and SAEs (time frame: Day 0 through 52 Weeks after KL-HIV-Tri01 administration). The study lists 4 primary outcomes in all. 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 8 Nov 2023.