HIV InfectionsTatLatNCT06441123
Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein
An observational study of HIV Infections, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells. These hidden cells contain HIV that is not active and do not produce the virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood Sampling
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to 10 Feb 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is aviremic HIV-positive individuals, with no age criterion, having a long history of HIV infection (nadir < 200 CD4/µL
Who may be able to join
- Patient aged 18 years or older
- HIV-positive
- On ART (antiretroviral therapy)
- HIV-1 RNA undetectable for more than 12 months
- Nadir CD4 count < 200/µL
Who cannot join
- Lack of antiretroviral treatment
- Immunosuppressive treatments
- History of cancer less than 5 years old
- Pregnant or breast-feeding women
- Persons protected by law (under guardianship or curators), persons under court protection
- Participating in another research project with an ongoing exclusion period
- Refusal to participate in research
- Subject not affiliated to a social security scheme, or not benefiting from such a scheme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bruno BEAUMELLE contact
France1 site, 1 recruiting
- Recruiting
CHU de MONTPELLIER
Montpellier, 34090
0467335046, a-makinson@chu-montpellier.fr
About this study
Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells. These hidden cells contain HIV that is not active and do not produce the virus. These cells are a major challenge in finding a cure for HIV.
One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents (LRAs). This process, known as the "shock-and-kill" strategy, involves waking up the hidden virus ("shock" phase) so that it can be destroyed by the body's immune system or by the virus itself ("kill" phase).
Investigators are developing new LRAs that target and activate a viral protein called Tat, which is necessary for the virus to start producing again and for reversing its dormant state.The lead compound, named D10, is the first of its kind to target the Tat protein. This compound has been patented and has shown activity in activating the virus in lab-grown cells. Now, investigators need to test its effectiveness on real target cells from people living with HIV.
Read the detailed description
20 ml of blood (5 tubes of 4 ml each) will be collected from 24 people living with HIV who are on ART. The inclusion criteria for this study are: being HIV-positive, having an undetectable viral load for more than 12 months, and having a history of very low T-CD4 counts (nadir < 200 cells/mm³).
In the lab, investigators will isolate immune cells (PBMCs) from the blood using a special technique. These cells will then be placed in small wells and treated with LRAs for 18-20 hours. Investigators will measure the virus produced in the cell supernatant using two methods: q-RT-PCR for viral RNA and p24 ELISA for viral protein. The results will be analyzed using conventional statistical methods.
- Conditions
- HIV Infections
- Being tested
- Blood Sampling
- Keywords
- HIV-1, Tat, latency, latency reversing agents, transcription
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingBiological
20 ml of blood (5 tubes of 4 ml) will be collected once.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of p24 in the cell supernatant 18-20 hours after the addition of the LRAs (Latency Reversing Agents)
Viral production is considered significant if the signal obtained from the p24 ELISA of these supernatants is more than twice the background observed in the absence of LRA
Measured: INCLUSION VISIT
Secondary outcomes (2)
Quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs.
quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs.
Measured: INCLUSION VISIT
Measure the effective dose of D10 to reverse the latency of latent HIV-infected PBMCs
effective dose of D10 to reverse the latency of latent HIV-infected PBMCs
Measured: INCLUSION VISIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Feb 2025
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Université Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441123
- Sponsor's protocol ID
- RECHMPL23_0276
- Acronym
- TatLat
- Status last verified
- Feb 2025
- First submitted
- 28 May 2024
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Family of HIV Latency Regulators (LRAs) Targeting the Tat Viral Protein
- ClinicalTrials.gov ID
- NCT06441123
- Acronym / sponsor ID
- TatLat / RECHMPL23_0276
- Conditions
- HIV Infections
- Keywords
- HIV-1, Tat, latency, latency reversing agents, transcription
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Université Montpellier
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 4 Jun 2024 (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.
Antiretroviral therapy (ART) prevents HIV from multiplying. However, if people living with HIV stop taking ART, the virus quickly reappears in their blood due to the random activation of hidden infected cells. These hidden cells contain HIV that is not active and do not produce the virus. These cells are a major challenge in finding a cure for HIV.
One of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents (LRAs). This process, known as the "shock-and-kill" strategy, involves waking up the hidden virus ("shock" phase) so that it can be destroyed by the body's immune system or by the virus itself ("kill" phase).
Investigators are developing new LRAs that target and activate a viral protein called Tat, which is necessary for the virus to start producing again and for reversing its dormant state.The lead compound, named D10, is the first of its kind to target the Tat protein. This compound has been patented and has shown activity in activating the virus in lab-grown cells. Now, investigators need to test its effectiveness on real target cells from people living with HIV.
Detailed description
20 ml of blood (5 tubes of 4 ml each) will be collected from 24 people living with HIV who are on ART. The inclusion criteria for this study are: being HIV-positive, having an undetectable viral load for more than 12 months, and having a history of very low T-CD4 counts (nadir < 200 cells/mm³).
In the lab, investigators will isolate immune cells (PBMCs) from the blood using a special technique. These cells will then be placed in small wells and treated with LRAs for 18-20 hours. Investigators will measure the virus produced in the cell supernatant using two methods: q-RT-PCR for viral RNA and p24 ELISA for viral protein. The results will be analyzed using conventional statistical methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is aviremic HIV-positive individuals, with no age criterion, having a long history of HIV infection (nadir < 200 CD4/µL
Key inclusion criteria (5 listed)
- Patient aged 18 years or older
- HIV-positive
- On ART (antiretroviral therapy)
- HIV-1 RNA undetectable for more than 12 months
- Nadir CD4 count < 200/µL
Key exclusion criteria (8 listed)
- Lack of antiretroviral treatment
- Immunosuppressive treatments
- History of cancer less than 5 years old
- Pregnant or breast-feeding women
- Persons protected by law (under guardianship or curators), persons under court protection
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 Sampling20 ml of blood (5 tubes of 4 ml) will be collected once. | Biological | – |
Primary outcome
Quantity of p24 in the cell supernatant 18-20 hours after the addition of the LRAs (Latency Reversing Agents)
Time frame: INCLUSION VISIT
Viral production is considered significant if the signal obtained from the p24 ELISA of these supernatants is more than twice the background observed in the absence of LRA
2 secondary outcomes
Quantity of viral RNA in the cell supernatant 18-20 hours after the addition of LRAs.
Time frame: INCLUSION VISIT
Measure the effective dose of D10 to reverse the latency of latent HIV-infected PBMCs
Time frame: INCLUSION VISIT
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 24 Feb 2025.
- 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.
Bruno BEAUMELLE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University Hospital, Montpellier at 1 site in France.
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 8 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Alain MAKINSON, Pr (04 67 33 83 40, a-makinson@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of p24 in the cell supernatant 18-20 hours after the addition of the LRAs (Latency Reversing Agents) (time frame: INCLUSION VISIT). 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 24 Feb 2025.